Clinical trials

This prospective, single-center interventional study aims to evaluate the effect of two commonly used intravenous antihypertensive agents - nicardipine and nitroglycerin - on lung ventilation-perfusion (V/Q) distribution in patients with acute respiratory failure complicated by hypertension. Electrical Impedance Tomography (EIT) will be used for noninvasive monitoring of pulmonary ventilation and perfusion distribution before and after drug administration. The study will compare the changes in V/Q ratio, oxygenation index, and hemodynamic variables after administration of the two drugs. The findings are expected to provide evidence for the optimal antihypertensive strategy in critically ill patients with respiratory failure and to clarify whether specific vasodilators exacerbate or improve ventilation-perfusion mismatch.

This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous anisodamine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, will require norepinephrine support after adequate fluid resuscitation, and will be receiving invasive mechanical ventilation and PiCCO-based hemodynamic monitoring. After baseline assessment, participants will receive intravenous anisodamine according to the study protocol. Anisodamine will be administered as a loading dose of 0.5 mg/kg within 3 minutes, with a minimum dose of 20 mg and a maximum dose of 40 mg, followed by continuous infusion at 0.02-0.1 mg/kg/hour, with a maximum total daily dose of 200 mg. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of anisodamine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived variables, and safety outcomes will also be collected. The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after anisodamine administration and to provide preliminary data for future controlled studies.

This prospective, multicenter, single-arm interventional pilot study aims to evaluate the short-term physiological effects of intravenous esmolol on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, persistent tachycardia after initial hemodynamic optimization, ongoing norepinephrine support, adequate volume status or absence of significant fluid responsiveness, and preserved or hyperdynamic cardiac function. Approximately 20 patients will be enrolled from participating intensive care units. After baseline assessment, participants will receive continuous intravenous esmolol infusion according to the study protocol and clinical safety criteria. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline and at 3, and 6 hours after esmolol initiation. Additional systemic hemodynamic, perfusion, vasopressor, and safety variables will also be collected. The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after esmolol administration and to provide preliminary data for the design of future controlled studies.

This is a prospective, multicenter, single-arm, open-label, pilot physiological study designed to evaluate the effects of intravenous papaverine on sublingual microcirculation and the vascular waterfall phenomenon in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, and have PiCCO-based hemodynamic monitoring available before papaverine administration. Papaverine will be administered as an intravenous infusion of 30 mg over 10 minutes, followed by a continuous infusion of 2-5 mg/hour. Sublingual microcirculatory variables, vascular-waterfall-related indices, PiCCO-derived hemodynamic variables, macrocirculatory parameters, tissue perfusion variables, vasopressor dose, and safety outcomes will be assessed before and after papaverine administration. The study aims to explore whether papaverine can improve microvascular perfusion and reduce microcirculatory flow impairment in septic shock, and to provide preliminary physiological and safety data for future controlled trials.

This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous dexmedetomidine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, receive invasive mechanical ventilation, and have PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation. After baseline assessment, participants will receive intravenous dexmedetomidine according to the study protocol. Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg/kg/hour without a loading dose. The infusion rate may be adjusted according to the target sedation level, hemodynamic status, and adverse effects. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of dexmedetomidine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived, sedation-related, and safety outcomes will also be collected. The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after dexmedetomidine administration and to provide preliminary data for future controlled studies.

This study aims to determine whether shear wave elastography (SWE), a non-invasive ultrasound technique that measures nerve stiffness, can help detect ICU-acquired weakness (ICU-AW) early in critically ill patients. Adults receiving mechanical ventilation in the ICU will undergo ultrasound examinations of the median and tibial nerves on Days 1, 4, and 7. The study will evaluate whether early changes in nerve elasticity can predict ICU-AW, which is usually diagnosed later using a muscle strength score that requires patient cooperation.

Patients with end-stage renal disease (ESRD) often require arteriovenous grafts (AVG) for hemodialysis. AVG thrombosis is a common complication, usually managed by percutaneous transluminal angioplasty (PTA) to restore blood flow. PTA achieves patency by balloon-mediated compression and fragmentation of thrombus. Small thrombus fragments may enter the venous circulation and cause transient pulmonary microembolism, leading to ventilation-perfusion (V/Q) mismatch. This study uses electrical impedance tomography (EIT) to noninvasively monitor short-term changes in regional ventilation and perfusion during and after PTA, exploring the immediate pulmonary physiological consequences of thrombus fragmentation and revascularization in dialysis patients.

This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation. Eligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure. This study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.

This study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition characterized by excessive inflammation and organ dysfunction. The primary objective is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce circulating inflammatory cytokine levels in this patient population. Eligibility Criteria: Adults aged 18 years or older Diagnosed with septic shock and admitted to the ICU within 24 hours Expected to require intensive care for at least 72 hours Study Protocol: Participants will be randomly assigned to one of two groups: Intervention Group: Will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days, using a portable device. Control Group: Will receive standard septic shock care alone. Blood samples will be collected at baseline and Day 5 to measure inflammatory cytokine levels, including TNF-α, IL-1β, IL-6, and IL-10. Additional assessments will include lymphocyte subpopulations, organ function scores, ICU length of stay, 28-day mortality, and adverse events. Outcome Measures: Primary: Change in levels of inflammatory cytokines on Day 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention.

This single-center randomized controlled study aims to evaluate the effectiveness of Case-Based Learning (CBL) compared with traditional teaching in clinical training of bedside lung ultrasound (BLUE) for emergency medicine residents and medical students. The hypothesis is that CBL improves theoretical understanding, practical ultrasound skills, and clinical reasoning in emergency settings.

This is a multicenter, randomized-controlled, open-label, blinded endpoint clinical trial that aims to evaluate the efficacy and safety of hemoadsorption for severe ischemic stroke

A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for acute patients with a Large Core Infarction.

Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END). Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials. The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.

Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score \>5. Thus, a sizeable fraction of patients with a minor stroke that do not undergo cerebrovascular screening may experience an early neurological deterioration (END) due to LVO, possibly leading to poor long-term functional outcome. However, whether these patients may still benefit from a rescue EVT is unknown, especially in a late window (\>24 hours). In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone in a late window for minor stroke patients who have experienced an LVO and END. The primary objective of the study was to establish the safety and efficacy of EVT in a late window for minor stroke patients in the anterior circulation who experienced an LVO and END.

The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of Sodium-Glucose Co-Transporter 2 Inhibitors(SGLT2i) and finerenone can provide additional kidney protection and safety for Chinese adults with Type 2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease(CKD). Eligible participants will be adults with T2DM and mild-to-moderate CKD who have been receiving SGLT2 inhibitor plus finerenone for at least 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi). Participants will be randomly assigned to either continue the original regimen or to receive add-on therapy with dulaglutide.The study will last for 26 weeks, with participants required to attend scheduled visits for efficacy and safety assessments at Week 13 (±1 week) and Week 26 (±1 week, final visit).

The goal of this observational pilot study is to learn if sodium bicarbonate can be used safely and effectively as a contrast agent to map lung blood flow using electrical impedance tomography (EIT) in adults on mechanical ventilation. Electrical impedance tomography (EIT) is a bedside imaging method that uses a soft belt with small sensors around the chest to track changes in electrical signals related to breathing and blood flow. The main questions are: Does sodium bicarbonate create clear, readable lung blood flow images with EIT? Are these images similar in quality and pattern to images made with hypertonic saline (10% sodium chloride)? Is the short-term safety profile acceptable, including effects on blood pressure, heart rhythm, and blood tests? Researchers will compare two contrast agents within the same participant to see if image quality and lung blood flow patterns match: Hypertonic saline (10% sodium chloride) Sodium bicarbonate (5%) Participants will: Have an EIT belt placed around the chest during routine ICU care Pause the ventilator briefly during image capture to reduce motion Receive two small intravenous boluses through an existing central line, one of hypertonic saline and one of sodium bicarbonate, with time between doses Have routine monitoring of vital signs; blood gases and electrolytes may be checked per clinical care Be observed for any short-term side effects Findings from this study will show whether sodium bicarbonate is a practical and safe option for EIT-based lung blood flow assessment and will guide larger future studies.

This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia. A total of 426 patients with severe stroke (including ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage) within 24 hours of onset and blood glucose \>10 mmol/L at randomization will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either delayed antihyperglycemic treatment (initiated on Day 4) or early antihyperglycemic treatment (initiated on Day 1). Glycemic control targets (7.8-10.0 mmol/L) and insulin therapy follow current clinical guidelines. The primary outcome is the incidence of poor functional outcome (modified Rankin Scale score ≥ 3) at 90 days. Secondary outcomes include mortality, NIHSS score, GCS score, ICU length of stay, and safety events such as hypoglycemia and infections. The study aims to provide evidence on the optimal timing of glycemic control in severe stroke patients with stress hyperglycemia.

This multicenter, prospective observational study aims to evaluate the predictive value of the Inferior Vena Cava Collapsibility Index (IVCCI), along with IVC maximum diameter (IVCmax) and IVC minimum diameter (IVCmin), for intradialytic hypotension in patients undergoing maintenance hemodialysis. The study will be conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital. Eligible participants are adults aged 18 years or older with diagnosed end-stage renal disease (ESRD), receiving regular hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors likely to influence results will be excluded. Ultrasound measurements of IVCCI, IVCmax, and IVCmin will be performed once, precisely at 1 hour after dialysis initiation. IVCmax will be measured during inspiration when the IVC is at its largest, and IVCmin during expiration when it is at its smallest. Blood pressure will be monitored continuously during the procedure. The primary objective is to assess the sensitivity, specificity, and optimal cutoff values of IVCCI, IVCmax, and IVCmin for predicting hypotension, aiming to provide a simple and non-invasive tool to facilitate personalized dialysis management and reduce intradialytic hypotension. A sample size of 188 participants is estimated, with data analyzed using ROC curves and multivariate regression methods. The study protocol adheres to ethical standards and regulatory requirements, demonstrating potential to improve patient safety and treatment outcomes.

This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.

This is a multicenter, prospective, randomized, controlled study that will enroll approximately 429 subjects. The screening period will last 4-8 weeks. Subjects will undergo pre-screening based on eGFR and urinary albumin-to-creatinine ratio (UACR). Only non-dialysis subjects meeting the following criteria confirmed by local laboratories within 6 months prior to screening will be eligible for central laboratory screening: 10 mL/min/1.73m² ≤ eGFR \< 30 mL/min/1.73m² and 150 mg/g (16.95 mg/mmol) ≤ UACR \< 5000 mg/g (565 mg/mmol). Unless contraindicated due to intolerance, subjects with 20 mL/min/1.73m² ≤ eGFR \< 30 mL/min/1.73m² must receive stable, maximally tolerated labeled daily doses of ACEi or ARB for at least 4 weeks prior to randomization. For subjects with 10 mL/min/1.73m² ≤ eGFR \< 20 mL/min/1.73m², investigators will determine ACEi/ARB treatment based on patient condition per KDIGO guidelines. Other antihypertensive, lipid-lowering, and glucose-lowering therapies should be stabilized for approximately 4 weeks before randomization. Investigators are encouraged to maintain stability of medications known to affect serum creatinine levels during screening and approximately 2 weeks prior to any serum chemistry measurements throughout the study. Eligible subjects will be randomized in a 1:1:1 ratio to receive Henagliflozin (10 mg q.d., 5 mg q.d.) or conventional therapy. Thereafter, subjects will undergo laboratory assessments, concomitant medication review, adverse event collection, and clinical endpoint ascertainment at Week 4 (Day 30), Week 12 (Day 90), and Week 24 (Day 180), followed by every 12-week intervals. Throughout the study, all subjects will receive glycemic, blood pressure (target SBP \<140 mmHg and DBP \<90 mmHg), and lipid management according to current guidelines. All subjects will complete an end-of-study visit. Subjects discontinuing study drug prematurely should continue all subsequent study visits.

What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Our goal is to find out if monitoring PVI can help identify patients at risk, so that early action can be taken. Who can join? Adults aged 18 to 80 years. Patients who have been receiving maintenance hemodialysis regularly for more than 3 months. Those who are willing and able to participate and sign an informed consent form. Who cannot join? Patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes PVI measurement unreliable. Patients who are pregnant or breastfeeding. Patients allergic to the dialysis filter or unable to cooperate with the study procedures. What will happen during the study? PVI Measurement: Your PVI will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins. Blood Pressure Monitoring: Your blood pressure will be closely watched throughout the dialysis session. Data Collection: Information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded. What are the benefits and risks? Benefits: By identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future. Risks: All measurements used in this study are safe and non-invasive, with no extra risk compared to routine care. Your Rights and Safety Participation is completely voluntary-you may leave the study at any time without affecting your medical care. The study has been reviewed and approved by the hospital's ethics committee. Your privacy and personal data will be strictly protected.

What is this study about? This study is designed to evaluate whether ultrasound-guided removal of microbubbles during circuit priming in Continuous Renal Replacement Therapy (CRRT) can extend the filter lifespan for critically ill patients who require CRRT. The investigators aim to determine if this technique improves the duration of effective filter use and reduces complications related to filter clotting. Who can join? Adults (18 years or older) admitted to the Intensive Care Unit (ICU) and diagnosed with acute kidney injury (AKI) or chronic kidney failure (CKD) who require CRRT and are expected to undergo at least two sessions of CRRT treatment. Participants or their legal representatives must provide signed informed consent. Who cannot join? Patients with severe coagulation disorders, platelet count \<30×10\^9/L, contraindications to anticoagulation, significant changes in clinical scores or blood tests between CRRT sessions, or any other condition deemed unsuitable by the investigator. What will happen during the study? Two Treatment Methods: Conventional Priming (Control): The CRRT circuit will be primed following the standard visual bubble inspection protocol. Ultrasound-Guided Priming (Intervention): The circuit will be primed using real-time ultrasound to detect and remove microbubbles from key locations. Each participant will receive both interventions in random order, separated by a washout period of at least 24 hours. Safe and Routine Monitoring: Ultrasound scans will be performed on the filter and circuit to guide microbubble removal. Standardized CRRT treatment protocols, including filter type and anticoagulation regimen, will be used for all sessions. Other Data Collection: Patient information (e.g., age, sex, medical history, APACHE II score) CRRT treatment details (e.g., filter lifespan, filter clotting incidence, coagulation parameters) Monitoring of adverse events and clinical outcomes (including 28-day survival and treatment costs) What are the benefits and risks? Benefits: This study may provide evidence for a simple, non-invasive method to reduce filter clotting, improve CRRT efficiency, and enhance patient outcomes. Risks: Ultrasound monitoring is non-invasive and does not add risk beyond standard care. All procedures are standard clinical practice. Your Rights and Safety Voluntary Participation: Participation is voluntary; withdrawal is allowed at any time without affecting clinical care. Ethical Approval: The study protocol is reviewed and approved by the hospital's ethics committee. Confidentiality: All personal information and test results will be kept confidential.

This multicenter, ambispective cohort study establishes a comprehensive multiomics biobank from five stroke centers, encompassing thrombi, intracranial blood, peripheral arterial/venous blood, and clinical-laboratory-imaging-follow-up data from patients with acute ischemic stroke with large vessel occlusion (AIS-LVO).

A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.