Clinical trials

Acute respiratory distress syndrome (ARDS) is a common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Differences in patients' inflammatory responses, baseline immune function, and organ failure patterns contribute to variability in ARDS severity, treatment response, and clinical outcomes. Precision classification of ARDS based on biological and inflammatory characteristics may therefore be essential for improving patient outcomes. Previous analyses of randomized clinical trials have identified two reproducible inflammatory subphenotypes-"hyperinflammatory" and "hypoinflammatory"-which differ in organ dysfunction profiles, clinical trajectories, and responses to treatments such as fluid management strategies, corticosteroids, and ventilatory interventions. However, key uncertainties remain, including whether these inflammatory subphenotypes can be validated in Chinese ARDS populations, how various bedside prediction models perform in identifying these subphenotypes, and whether model-based subphenotype identification can guide individualized treatment decisions. This multicenter cohort study aims to: (1) validate inflammatory subphenotypes of ARDS using latent class analysis; (2) compare the predictive performance of existing bedside models for subphenotype identification; and (3) assess whether subphenotype assignment based on prediction models can guide individualized treatment strategies, including fluid management, PEEP titration, and corticosteroid use. In addition to these primary aims, the study may include other exploratory objectives, such as evaluating subphenotype stability over time, characterizing biological pathways associated with subphenotypes, and assessing additional treatment-response patterns to support future precision ARDS management strategies.

This prospective observational translational cohort study will investigate whether extra-pulmonary infection caused by hypervirulent Klebsiella pneumoniae (hvKP) is associated with an increased risk of sepsis-associated acute lung injury (SALI), compared with infection caused by classical Klebsiella pneumoniae (cKP). The study will further examine whether circulating bacterial outer membrane vesicle (OMV) signals and ferroptosis-related biomarker profiles are associated with subsequent SALI development. Adults with Sepsis-3 and microbiologically confirmed extra-pulmonary K. pneumoniae infection will be enrolled within 6 hours of sepsis recognition. Patients with acute lung injury at enrollment will be excluded from the primary cohort. Blood samples will be collected at enrollment, 24 hours, and 72 hours. Clinical isolates will undergo molecular characterization to classify infections as hvKP or cKP. The primary outcome will be new-onset SALI within 7 days after enrollment. A nested translational substudy will evaluate the effects of patient-isolate-derived OMVs on human pulmonary microvascular endothelial cells. The study will not alter antimicrobial therapy, source control, respiratory support, fluid management, or any other aspect of routine clinical care.

Postoperative gastric distension is a common gastrointestinal complication after cardiac surgery and may delay recovery, prolong intensive care unit (ICU) stay, and reduce patient comfort. Anti-bloating patches are widely used in clinical practice to promote gastrointestinal function recovery; however, high-quality evidence regarding their effectiveness in cardiac surgical patients remains limited. This randomized controlled trial aims to evaluate the efficacy and safety of an anti-bloating patch in reducing postoperative gastric distension after cardiac surgery. Adult patients undergoing cardiac surgery will be randomly assigned to receive either standard perioperative care alone or standard perioperative care plus anti-bloating patch therapy. Gastric bubble area will be quantitatively measured using chest radiographs and image analysis software. The primary outcome is the change in gastric bubble area on postoperative day 1 compared with baseline. Secondary outcomes include gastric bubble area on postoperative day 1, percentage change in gastric bubble area, abdominal distension score, time to first flatus, time to first bowel movement, gastric drainage volume, time to oral feeding, ICU length of stay, postoperative hospital length of stay, and patch-related adverse events. The results of this study may provide evidence for the use of anti-bloating patches as an adjunctive intervention to enhance postoperative gastrointestinal recovery in patients undergoing cardiac surgery.

Acute respiratory distress syndrome (ARDS) is a major cause of acute hypoxemic respiratory failure in critically ill patients and is associated with substantial mortality. Current management is largely supportive, and no pharmacologic therapy has been shown consistently to reduce mortality in a broad population of patients with ARDS. Inflammation plays a central role in the pathogenesis of ARDS. Excessive inflammatory activation contributes to alveolar-capillary injury, impaired gas exchange, and progression of organ dysfunction. Glucocorticoids may mitigate these processes and have been associated in some studies with improved clinical outcomes, including shorter duration of mechanical ventilation. However, the effect of glucocorticoids on survival remains uncertain. ARDS is a heterogeneous syndrome with diverse etiologies, and treatment response may vary according to the underlying cause. A post hoc analysis of the Dex-ARDS trial suggested that the treatment effect of glucocorticoids may be greater in ARDS caused by pneumonia or extrapulmonary sepsis. In a cross-sectional survey of 135 patients with ARDS from 20 ICUs in China, pneumonia- and extrapulmonary sepsis-associated ARDS accounted for 77.6% of cases, indicating that these are the predominant etiologic subtypes encountered in clinical practice in China. More importantly, compared with ARDS attributable to other causes, pneumonia- and extrapulmonary sepsis-associated ARDS has been associated with higher mortality, suggesting a greater disease burden, worse prognosis, and a more urgent need for improved treatment strategies. On this basis, the present trial will enroll patients with ARDS caused by sepsis, including pneumonia and extrapulmonary sepsis. The primary hypothesis of this study is that, among patients with sepsis-associated ARDS, dexamethasone plus usual care, as compared with placebo plus usual care, will reduce 90-day all-cause mortality. We therefore designed a multicenter, randomized, double-blind, controlled trial to evaluate the clinical efficacy of dexamethasone in patients with sepsis-associated ARDS. The primary objective is to compare dexamethasone plus usual care with placebo plus usual care with respect to 90-day all-cause mortality.

Acute respiratory distress syndrome (ARDS) is a common clinical syndrome in the ICU characterized by extremely high mortality and complex pathogenesis.At present, research on individualized treatment, phenotypic differences, and therapeutic efficacy in ARDS has become a hotspot.As characterized by syndrome differentiation, traditional Chinese medicine (TCM) treatment emphasizes interindividual heterogeneity and personalized management, which is expected to serve as a breakthrough in multi-target immune regulation for ARDS. The primary objective of the study is to investigate the effect of Xuanbai Shengmai Decoction on the prognosis of patients with ARDS in a prospective randomized controlled trial. The secondary objective is to evaluate the safety of Xuanbai Shengmai Decoction in the treatment of patients with ARDS.

The goal of this clinical trial is to learn whether bedside flexible bronchoscopy-guided airway clearance can improve lung aeration in adult patients who are receiving invasive mechanical ventilation and have atelectasis with a high airway secretion burden. The main questions it aims to answer are: Does bedside flexible bronchoscopy-guided airway clearance reduce the proportion of nonaerated lung tissue from baseline to day 5? Does this treatment improve other lung aeration measures, respiratory mechanics, arterial blood gas parameters, pulmonary infection score, ventilator-free days, intensive care unit length of stay, and safety outcomes? Researchers will compare usual airway care plus bedside flexible bronchoscopy-guided airway clearance with usual airway care alone to see if bronchoscopy-guided airway clearance improves lung aeration and clinical outcomes. Participants will be randomly assigned to one of two groups. Participants in the usual care group will receive standard airway management, which may include airway suctioning, postural drainage, humidification, chest physiotherapy, and other routine respiratory care. Participants in the bronchoscopy group will receive the same usual care, plus bedside flexible bronchoscopy-guided airway clearance when predefined criteria for high airway secretion burden are met. Participants will have clinical assessments during the study, including chest imaging, respiratory mechanics measurements, arterial blood gas tests, pulmonary infection score assessment, and safety monitoring. The main assessment will compare quantitative chest computed tomography findings at baseline and day 5 to evaluate changes in nonaerated lung tissue.

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in ARDS patients.

The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.

The goal of this clinical trial is to learn whether a phenotype-guided weaning strategy can help adults with chronic comorbidities be liberated from invasive mechanical ventilation earlier. It will also learn about the safety of this strategy. The main questions it aims to answer are: * Does the phenotype-guided weaning strategy increase the number of ventilator-free days within 28 days after enrollment? * Does the strategy improve the process and success of ventilator liberation? * What safety events occur when this strategy is used? Researchers will compare the phenotype-guided weaning strategy with standard care in mechanically ventilated patients with chronic cardiovascular, cerebrovascular, or respiratory comorbidities. In the intervention period, participants will receive a protocolized ventilator weaning pathway. This pathway includes assisted ventilation transition, daily weaning readiness screening, a 0 cmH2O continuous positive airway pressure test, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support when appropriate. The phenotype-guided part of the strategy is mainly used for participants who fail a spontaneous breathing trial or have difficult weaning. These participants will undergo structured ABCDE screening to identify the main phenotype or mechanism of weaning failure: * A: airway or lung dysfunction * B: brain dysfunction, including delirium, anxiety, agitation, or impaired consciousness * C: cardiac dysfunction * D: diaphragm or respiratory muscle dysfunction * E: endocrine, metabolic, or nutritional problems Based on the identified phenotype, clinicians will provide targeted assessment and treatment. Participants will be followed for ventilator-free days through day 28 and for clinical outcomes through day 90.

EARLY-VENT is a multicenter, open-label, three-period cluster-randomized crossover trial designed to evaluate whether early transition from controlled to assisted ventilation improves outcomes in critically ill patients. The study will enroll approximately 1,600 adult patients across 10 ICUs who are expected to require mechanical ventilation for at least 48 hours and meet specific stability criteria (e.g., hemodynamically stable, light sedation). Participating centers will alternate between an experimental strategy, where patients transition to an assisted mode (preferably Pressure Support Ventilation) within 6 hours of eligibility, and a control strategy based on standard care practices. The primary endpoint is the rate of successful extubation at day 28, aiming to demonstrate that transition from controlled to assisted ventilation can reduce ventilation duration and improve prognosis compared to delayed transition.

This study used a retrospective cohort study based on Multi-time longitudinal monitoring data were used to analyze the correlation mechanism between the dynamic evolution characteristics of nutrition-related biochemical indicators and individualized nutritional intervention in patients with mechanical ventilation. The inflammation-nutrition interaction model was constructed to correct the interference effect of inflammatory microenvironment on nutritional status assessment, so as to provide a basis for further achieving precision nutritional support.

This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Patients included will be randomly assigned to receive enteral nutrition either through a nasogastric tube or a nasojejunal tube. The primary endpoint is the achievement of enteral nutrition goals. Secondary endpoints include the incidence of hospital-acquired infections, the number of ventilator-free days within 28 days, ICU length of stay, ICU mortality, 28-day mortality, 60-day mortality rates, the incidence of enteral nutrition intolerance, and the rate of enteral nutrition intake.

Liposomal amphotericin B is an antifungal agent commonly used to treat invasive aspergillosis, a severe fungal infection associated with high mortality in critically ill patients. However, evidence regarding its safety and effectiveness in patients with hepatic dysfunction is limited. In China, patients diagnosed with invasive aspergillosis complicated by hepatic dysfunction will be recruited from multiple centers. Eligible patients will receive treatment with liposomal amphotericin B according to the study protocol. The safety and effectiveness of liposomal amphotericin B in this patient population will be evaluated. This study aims to provide clinical evidence to support antifungal treatment decisions for patients with invasive aspergillosis and impaired liver function.

Acute respiratory distress syndrome (ARDS) is a common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Differences in patients' inflammatory responses, baseline immune function, and organ failure patterns contribute to variability in ARDS severity, treatment response, and clinical outcomes. Precision classification of ARDS based on biological and inflammatory characteristics may therefore be essential for improving patient outcomes. Previous analyses of randomized clinical trials have identified two reproducible inflammatory subphenotypes-"hyperinflammatory" and "hypoinflammatory"-which differ in organ dysfunction profiles, clinical trajectories, and responses to treatments such as fluid management strategies, corticosteroids, and ventilatory interventions. However, key uncertainties remain, including whether these inflammatory subphenotypes can be validated in Chinese ARDS populations, how various bedside prediction models perform in identifying these subphenotypes, and whether model-based subphenotype identification can guide individualized treatment decisions. This multicenter cohort study aims to: (1) validate inflammatory subphenotypes of ARDS using latent class analysis; (2) compare the predictive performance of existing bedside models for subphenotype identification; and (3) assess whether subphenotype assignment based on prediction models can guide individualized treatment strategies, including fluid management, PEEP titration, and corticosteroid use. In addition to these primary aims, the study may include other exploratory objectives, such as evaluating subphenotype stability over time, characterizing biological pathways associated with subphenotypes, and assessing additional treatment-response patterns to support future precision ARDS management strategies.

Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. However, substantial heterogeneity exists in treatment response to PPV. Previous studies suggest that lung morphology-focal versus non-focal patterns based on chest CT-may influence responses to ventilatory strategies, but whether lung morphology modifies the effect of PPV remains unclear. In addition, the benefits and safety of PPV in patients with acute brain injury (ABI) complicated by ARDS are uncertain. Although PPV improves oxygenation, it may impair cerebral venous drainage and increase intracranial pressure, raising concerns about its use in ABI patients. Evidence from randomized trials in this population is limited and excludes patients with more severe hypoxemia or elevated intracranial pressure. Furthermore, the optimal duration and termination criteria for PPV are not well established. While PPV improves alveolar recruitment and reduces ventilator-induced lung injury, prolonged PPV may lead to excessive sedation exposure and PPV-related complications. Identifying the appropriate timing to discontinue PPV may help balance clinical benefits and potential harms.This study is a prospective, multicenter registry enrolling patients with moderate-to-severe ARDS. The objectives are: (1) To determine whether lung morphology can guide individualized PPV strategies; (2) To evaluate the effectiveness and safety of PPV in patients with ARDS complicated by acute brain injury; (3) To investigate the optimal timing for termination of PPV through target trial emulation methods.In addition to these core objectives, the study will include other exploratory aims.

Although the theoretical model of "cyclic on-off switching of pulmonary blood flow" provides a crucial perspective for understanding VILI, its clinical validation and real-time intervention face significant obstacles. The fundamental reason lies in the lack of pulmonary microcirculation monitoring technology capable of bedside, non-invasive, continuous operation with sufficient spatiotemporal resolution. Nowadays, a novel 3D-EIT can perform real-time and non-invasive assessment of the distribution of pulmonary blood flow. However, if 3D-EIT can help to identify "cyclic on-off switching of pulmonary blood flow" is still unclear.

Patients with acute hypoxemic respiratory failure (AHRF) typically present with pathophysiological alterations characterized by the coexistence of respiratory dysfunction and hypoxemia. Respiratory dysfunction leads to dyspnea, increased work of breathing, use of accessory respiratory muscles, and hypercapnia, while gas exchange impairment results in hypoxemia. Studies have shown that hypercapnia, acidosis, and hypoxemia can all enhance inspiratory effort, which further increases negative intrathoracic pressure. In these patients, regional differences in airway resistance and lung compliance are often present, causing redistribution of air within the lungs. This redistribution manifests as gas movement from non-dependent to dependent regions, known as "pendelluft," which amplifies regional alveolar strain and ventilation heterogeneity. This phenomenon becomes more pronounced during noninvasive respiratory support when spontaneous breathing is preserved. Noninvasive respiratory support strategies mainly include high-flow nasal oxygen (HFNO), noninvasive positive pressure ventilation (NIV), and continuous positive airway pressure (CPAP). HFNO delivers high-flow gas through nasal cannulas, generating a certain level of positive end-expiratory pressure (PEEP) and flushing out anatomical dead space to improve gas exchange, thereby reducing inspiratory effort, lowering the work of breathing, and enhancing oxygenation. NIV, typically using pressure support ventilation (NIV-PSV), is a patient-triggered, pressure-targeted mode that provides inspiratory positive pressure above PEEP. By augmenting tidal volume and reducing inspiratory effort, NIV improves gas exchange; however, leaks may limit the effective delivery of PEEP, and full inspiratory synchronization can increase transpulmonary driving pressure and tidal volume. CPAP, by contrast, delivers a constant positive pressure during both inspiration and expiration. Compared with HFNO, CPAP generates higher PEEP, which facilitates alveolar recruitment and more effectively improves oxygenation. Relative to NIV, CPAP may reduce transpulmonary driving pressure and tidal volume. Different noninvasive respiratory support strategies exert varying effects on respiratory drive and regional lung strain, leading to differences in the occurrence and magnitude of pendelluft. Physiological studies have suggested that CPAP may offer greater benefits in improving oxygenation and reducing inspiratory effort; however, whether it can mitigate the occurrence and extent of pendelluft remains uncertain. Therefore, this study was conducted to visualize and quantitatively assess pendelluft in real time using electrical impedance tomography (EIT), aiming to verify whether CPAP has a superior effect in reducing pendelluft in patients with AHRF.

With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.

Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator. Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus. We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.

This study examines how the interaction between octanal (an OR6A2 receptor activator) and OR6A2 expression influences inflammation and clinical outcomes in Myocardial Ischemia-Reperfusion Injury patients. We analyze two key relationships: 1) The octanal-OR6A2 pathway's association with systemic oxidative stress/inflammatory biomarkers, and 2) How OR6A2 expression patterns on monocyte subtypes and plasma octanal levels correlate with major cardiovascular events. Patients undergoing this post-revascularization injury provided blood samples for OR6A2/octanal/inflammation measurements. IR Injury patients underwent 44-month clinical follow-up. Results may identify biological markers for personalized risk assessment after revascularization therapies. Ethics approval: Zhongda Hospital #2020ZDSYLL051-P01.

Xuebijing injection (XBJ) showed proven efficacy in the EXIT-SEP trial (NCT03238742), lowering 28-day mortality. However, its real-world effectiveness requires validation due to the trial's strict criteria. Broader clinical evaluation is imperative.

Sepsis poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients diagnosed according to Sepsis-3.0 criteria across diverse settings, thereby generating actionable evidence to improve the quality of sepsis care nationwide.

Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.

The objective of this study is to determine whether continuous infusion of ceftazidime-avibactam (CAZ-AVI) could improve clinical outcomes in critically ill patients compared with intermittent infusion.

Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.