FLUid management and InDividualized resuscitation in Sepsis (FLUIDS)-A Study protocol for a single-centre, open-label, randomized clinical trial.
Sanne Ter Horst, Ewoud Ter Avest, Jildou van Everdink...
https://pubmed.ncbi.nlm.nih.gov/41417807Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07009665
Fluid Management and Individualized Resuscitation in Sepsis
Led by University Medical Center Groningen · Updated on 2025-12-19
188
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a personalized treatment approach can improve care for adults with sepsis in the emergency department. Sepsis is a serious condition caused by the body's uncontrolled response to infection, which can lead to low blood pressure, organ failure, and death. This study aims to see if adjusting fluid and blood pressure medicine based on how the heart responds can provide safer and more effective care compared to the standard fluid treatment. Participants will be randomly assigned to one of two groups. In the personalized treatment group, fluids and vasopressors (medicines that raise blood pressure) are given based on heart response measured with a non-invasive monitor tracking stroke volume index. The standard care group will receive fluids according to current guidelines, typically 30 milliliters per kilogram of body weight, as decided by their doctor. Treatment and monitoring focus on the first three hours after study enrollment. During the study, researchers will monitor the amount of fluids given, timing and use of vasopressors, blood pressure and circulation response, signs of organ recovery or damage, length of hospital stay, and any side effects. Participants will be followed during hospitalization, which averages about two weeks. The main outcome measured is the volume of intravenous fluids given within the first three hours, along with various secondary outcomes related to organ function and recovery.
CONDITIONS
Brief Title
Fluid Management and Individualized Resuscitation in Sepsis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years of age or older)
- Referred to internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, rheumatology, gastrointestinal/liver medicine, urology, or emergency medicine (non-trauma)
- Confirmed or suspected infection based on physician's judgment, including signs such as abnormal body temperature, high white blood cell count, increased C-reactive protein, or infection symptoms
- Need for hemodynamic resuscitation indicated by low blood pressure, high lactate levels, or high shock index
- Enrolled within one hour after arriving at the emergency department
You will not qualify if you...
- Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, burn or trauma injury, diabetic ketoacidosis, hyper-osmolarity syndrome, or pancreatitis
- Known aortic insufficiency, aortic abnormalities, or heart defects such as ventricular or atrial septal defects
- Advanced heart failure (NYHA IV), waiting for heart transplant, left ventricular assist device recipient, or chronic inotrope use
- End-stage kidney disease requiring dialysis or very low kidney function
- Decompensated liver cirrhosis with complications such as ascites, hepatic encephalopathy, or variceal bleeding
- Hemodynamic instability due to active bleeding
- Received more than 1 liter of intravenous fluid before study randomization
- Requires immediate surgery
- Transferred from another hospital or ICU after therapy started
- Pregnant women
- Trauma patients
- Suspected intra-abdominal hypertension due to portal hypertension
- Inability to obtain intravenous access
- Patient does not follow treatment protocol
- Excluded by clinician's opinion
- Unable to start treatment protocol within 1 hour after randomization
- Unwanted ICU admission due to advanced care directive or limited life expectancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - Up to 1 hour before enrollment
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Up to 3 hours
Participants receive hemodynamic resuscitation guided by either personalized stroke volume measurements or standard care involving intravenous fluids and/or vasopressors during the first 3 hours after enrollment.
1 treatment period immediately after enrollment
Follow-up
Duration - Up to 30 days
Participants are monitored for clinical outcomes including organ function, fluid balance, and adverse events for up to 30 days after treatment.
Regular assessments during hospital stay and follow-up as needed
Trial Site Locations
Total: 1 location
1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
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Research Team
S
Sanne Ter Horst, MD
S
Sanne Ter Horst, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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