Critically Ill Intensive Care Unit Patients

9

Review clinical trials related to Critically Ill Intensive Care Unit Patients. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

FMT for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients

Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay, and increased 90-day mortality. In critically ill ICU patients, severe gut microbiota dysbiosis and intestinal barrier impairment may occur due to the burden of primary critical illnesses, as well as the administration of proton pump inhibitors and antibiotics. This cascade contributes to a high prevalence of gastrointestinal dysfunction, alongside profound gut-derived systemic inflammatory responses and organ damage. Given the pivotal role of gut microbiota in maintaining intestinal homeostasis, fecal microbiota transplantation (FMT) holds promise as a novel therapeutic strategy for enteral feeding intolerance secondary to gastrointestinal dysfunction in critically ill ICU patients. This study intends to deliver FMT via a nasojejunal tube to critically ill patients with gastrointestinal dysfunction admitted to the ICU. Its objectives are to evaluate the intervention's effects on gastrointestinal function recovery and the alleviation of enteral feeding intolerance, while also assessing its impacts on intestinal barrier function, gut microbiota composition and metabolic profiles, serum metabolite signatures, immune-inflammatory responses (including lymphocyte subsets, cytokines, C-reactive protein, and procalcitonin), ICU delirium, ICU sleep quality, and clinical outcomes (encompassing ICU mortality, in-hospital mortality, 28-day all-cause mortality, 90-day all-cause mortality, 90-day readmission rate, and 90-day incidence of secondary infections).

Participants needed: 60
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUpdated: Jun 11, 2026Locations: 1
Eligibility criteria

Aged 18 to 70 years inclusive, regardless of ethnicity or gender; [+6]

Severe systemic infection in the early resuscitation phase, with hemodynamic ins... [+11]

Status: Recruiting

Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. In critically ill patients, drug levels can vary widely due to factors like surgery, inflammation, fluid resuscitation, or extracorporeal support, increasing the risk of underdosing. Rezafungin is a new antifungal agent with a long half-life and broad activity against Candida species, offering potential advantages in this setting. However, there is currently no data on its concentration or effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis. Its long half-life, coupled with repeated pharmacokinetic variations in critical care settings and the risk of insufficient concentrations, may hinder its use in this population.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Central Hospital, Nancy, FranceUpdated: Apr 1, 2026Locations: 1
Eligibility criteria

age > 18 years [+3]

death expected within 24h [+1]

Status: Recruiting

Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes

Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched"). The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.

Participants needed: 11,082
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Michelle ZellerUpdated: Mar 12, 2026Locations: 8
Eligibility criteria

Adults (age ≥18); [+2]

Requirement for a specialized RBC product or unit not readily available in inven... [+3]

Status: Recruiting

Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit

Researchers at the Department of Intensive Internal Medicine and the Department of Endocrinology and Diabetology will conduct a study to verify the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients in intensive internal care. Almost 150,000 people in Slovenia have diabetes, so keeping a close eye on blood sugar levels is key to preventing complications. The new sensors for continuous monitoring are available over the counter and certified as medical devices. The study will include at least 100 patients who will need blood sugar monitoring during their stay in the intensive care unit. Each patient will have two small sensors placed on each upper arm to continuously measure their blood sugar levels, but these values will not be visible to medical staff. At the same time, healthcare professionals will perform routine blood sugar measurements, and researchers will then compare the accuracy of both methods. The procedure is safe and painless, and patients will receive the same quality of care as usual.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Medical Centre MariborUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

Admission to the intensive care unit [+2]

Age under 18 [+2]

Status: Recruiting

SOFA-2 Score in Turkish ICUs

This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye. SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. It is an updated version of the original SOFA score and reflects modern intensive care practices. In this multicenter observational study, adult patients admitted to participating intensive care units will be followed during their ICU stay. SOFA and SOFA-2 scores will be calculated during the first 24 hours of admission, and in patients with longer stays, additional scores will be recorded. No additional tests or treatments will be performed as part of the study. The main goal of the study is to examine the relationship between SOFA-2 scores and intensive care unit mortality. The results are expected to help clinicians better assess disease severity and outcomes in critically ill patients.

Participants needed: 5,200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUpdated: Jan 21, 2026Locations: 1Duration: 60 Days
Eligibility criteria

Adults aged 18 years or older [+2]

Patients younger than 18 years [+3]

Status: Recruiting

Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients

The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). The educational intervention is based on a literature review of current recommendations for a more rational use of antimicrobials and microbiological tests in daily ICU practice. The main questions it aims to answer are: * Does the educational intervention reduce the antimicrobial consumption in the intensive care units? * Does this educational intervention aiming to reduce antimicrobial utilization in accordance with the latest guidelines have any safety signals regarding ICU mortality rates or ICU length-of-stay? Researchers will compare (1) ICUs sequentially randomized to this quality improvement educational intervention aimed at improving antimicrobial utilization to (2) the same ICUs at months where the educational intervention has not been delivered yet. Each participant ICU will transition to the quality improvement intervention approximately each month, starting at July, 2025. This quality improvement intervention is based on current recommendations for antimicrobial stewardship from regulatory agencies and medical societies, including cognitive aids for physicians to improve decision-making regarding the commencement of antimicrobials, their duration and antimicrobial time-outs. The investigators hypothesize that intensivists (ICU doctors) need to embrace antimicrobial stewardship as a core competence of their daily activities.

Participants needed: 9,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital Sirio-LibanesUpdated: Dec 3, 2025Locations: 9
Eligibility criteria

ICU leadership acceptance to participant in the quality improvement intervention... [+3]

All patients admitted to the intensive care unit [+1]

Status: Not yet recruiting

Ketamine Sedation in the ICU (KANINE) RCT

Sedation is given to intensive care unit (ICU) patients to treat discomfort, anxiety, agitation, and to help facilitate care, particularly when they require a breathing tube. Sedation is very commonly used in the ICU with North American data showing almost 40% of ICU patients get sedation to help when they are requiring a breathing machine. Various medications can be given intravenously to provide sedation in the ICU but there are side-effects associated with each such as decreasing a patient's own drive to breathe, and delirium or acute confusion, both of which are associated with worse outcomes. Also, most drugs used for sedation don't treat pain. As a result, many ICU patients are also given narcotics for pain control which can result in tolerance, dependence, and withdrawal. Ketamine is a sedating medication that also treats pain and is often used in the Emergency Department and in the Operating Room but for whatever reason is not commonly used in the ICU. The investigators are proposing a study to examine the usefulness and safety of adding an intravenous infusion of ketamine to usual care in adult patients that are on a breathing machine in the ICU. Study Methods The KANINE study is being done at hospitals across Ontario, Canada. It is a randomized controlled trial which means patients will be randomized (akin to a coin flip) to receive ketamine or usual care without ketamine. The study will be blinded which means that neither patients or the doctors will know if the patient is getting ketamine or not, those that get randomized to usual care without ketamine will get an intravenous solution that looks the same as the ketamine infusion. This is important to make sure the results aren't biased in any way. The investigators will include adult ICU patients on a breathing machine who are early in their ICU admission. As most patients will be unconscious, the investigators will ask substitute decision makers (families or caregivers) of patients for informed consent prior to the study commencing. Regardless of whether patients get randomized to ketamine or not, the investigators will make sure that all patients will be adequately sedated and have their pain managed as per usual care. Setting This study will be performed in adult ICUs across Canada. Population The investigators will include adults admitted to the ICU on a breathing machine and expected to remain mechanically ventilated beyond the calendar day after randomization. The investigators will exclude patients if: (i) they were admitted with a brain bleed, traumatic brain injury, or stroke; (ii) Admitted with uncontrolled high blood pressure; (iii) admitted with status asthmaticus; (iv); admitted to the ICU with partial thickness burns greater than 10% total body surface area or any full thickness burns; (v) if they have a history of schizophrenia; (vi) if they have very bad liver failure; (vii) if they are palliative or only for comfort care; (viii) if they are requiring very high doses of blood pressure support medication to increase their blood pressure; (ix) if they are receiving a medication that causes paralysis, sometimes used in patients with very bad lung disease; (x) if they have a tracheostomy which means a whole in their neck that they breathe through; (xi) if they are allergic to ketamine; (xii) if they've had a liver transplant in the last month; (xiii) if they are pregnant or breast-feeding. Outcomes The investigators will follow all the study patients to see if their outcomes are different depending on whether they get randomized to ketamine or not. The investigators will capture how much time they are on the breathing machine, whether they survive or die, how long they stay in the ICU and whether they require a tracheostomy which is a procedure often done on patients who require the breathing machine over a prolonged period of time. The investigators will also capture how often they get delirious and for those that get delirious how long it lasts for. The investigators will capture how much of other sedating medications study patients use such as antipsychotics and benzodiazepines. The investigators will capture outcomes such as how often study patients get post-traumatic stress disorder after leaving the ICU and how well their pain relief is addressed during their ICU stay. Finally, the investigators will capture side effects related to ketamine or other sedating drug use.

Participants needed: 54
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: McMaster UniversityUpdated: Sep 22, 2025Locations: 3
Eligibility criteria

Adult patients (≥ 18 years) admitted to the ICU [+3]

Admitted with a primary diagnosis of intracranial hemorrhage, traumatic brain in... [+12]

Status: Not yet recruiting

Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients

This clinical trial aims to evaluate whether continuous passive motion (CPM) can prevent ankle joint contracture and muscle atrophy in critically ill patients receiving mechanical ventilation in the ICU. The study will also assess the feasibility and safety of implementing CPM therapy in this population. The primary objectives are: To determine whether CPM preserves ankle dorsiflexion range of motion during ICU immobilization. To assess whether ultrasound can detect changes in tibialis anterior muscle morphology in response to CPM. In this within-subject design, each participant will receive CPM therapy on one ankle while the contralateral ankle serves as the control. Outcomes related to joint mobility and muscle condition will be compared between the two sides. Participants will: Receive CPM treatment on one ankle for 30 minutes, twice daily, for up to 7 days or until ICU discharge. Undergo goniometric and ultrasound assessments at baseline and after the intervention. Continue to receive standard ICU care throughout the study period.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Shin Kong Wu Ho-Su Memorial HospitalUpdated: Jun 29, 2025Locations: 1
Eligibility criteria

Neuromuscular disorders [+6]

Status: Recruiting

Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study

The purpose of this study is to investigate the efficacy of droplet digital PCR (ddPCR) in identifying pathogenic organisms in ICU sepsis patients, aiming to find a method that allows early identification of pathogenic organisms and dynamic surveillance in order to assess the association between pathogenic species and loads and clinical characteristics and outcomes.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUpdated: Mar 17, 2025Locations: 1Duration: 1 Month
Eligibility criteria

Patients with first diagnosis of sepsis after ICU admission

Age under 18 years [+2]