Actively Recruiting
Fluid Management and Individualized Resuscitation in Sepsis
Led by University Medical Center Groningen · Updated on 2025-12-19
188
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out if a personalized treatment approach can improve care for people with sepsis in the emergency department (ED). Sepsis is a life-threatening condition that happens when the body has an uncontrolled response to an infection. This can lead to low blood pressure, organ failure, and death if not treated quickly. Right now, most people with sepsis receive a standard amount of fluids to raise their blood pressure. But this one-size-fits-all approach can lead to fluid overload and other complications. Because each person responds differently, this study will test whether a more personalized treatment-based on how the heart responds to fluids-can lead to safer and more effective care. The study will include 188 adults who come to the ED at the University Medical Centre Groningen (UMCG) with suspected sepsis in need of hemodynamic resuscitation. Everyone in the study will receive fluids to support their blood pressure. Participants will be randomly assigned to one of two groups: * Personalized treatment group: Fluids and vasopressors (medications that raise blood pressure) will be given based on how the heart responds to each fluid dose. This response is measured using a non-invasive monitor that tracks stroke volume index (ΔSVI)-a measure of how much blood the heart pumps. * Standard care group: Fluids will be given based on current guidelines (30 milliliters per kilogram of body weight), as decided by the treating doctor. Researchers will compare how much fluid is given during the first 3 hours of care. They will also look at: * When and how much vasopressor medicine is used * How well blood pressure and circulation respond * Signs of organ recovery or damage * How long participants stay in the hospital * Any problems or side effects during treatment The researchers hope that this personalized approach will lead to using less fluid, starting vasopressors earlier, and helping people with sepsis recover more safely and quickly.
CONDITIONS
Official Title
Fluid Management and Individualized Resuscitation in Sepsis
Who Can Participate
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 and signs such as abnormal body temperature, leukocyte count, or C-reactive protein, or symptoms like productive cough, dyspnea, dysuria, or abdominal pain
- Need for hemodynamic resuscitation shown by any of: mean arterial pressure less than 70 mmHg, systolic blood pressure less than 90 mmHg or decrease over 40 mmHg, lactate over 4.0 mmol/L, or shock index over 0.9
- Enrollment in the study within one hour after arrival to 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
- Known advanced heart failure including NYHA IV class, waiting for heart transplant, LVAD recipient, or chronic inotrope use
- Known end-stage kidney disease requiring dialysis or with very low kidney function
- Decompensated liver cirrhosis at emergency department admission
- Hemodynamic instability due to active bleeding
- Received more than 1 liter of IV fluid before study randomization
- Requires immediate surgery
- Transfer from another hospital or in-hospital setting after starting therapy
- Pregnant women
- Trauma patients
- Suspected intra-abdominal hypertension based on portal hypertension signs
- Inability to obtain intravenous access
- Patient uncouples from treatment algorithm
- Exclusion based on clinician or investigator opinion
- Unable to start treatment protocol within 1 hour after randomization
- Advanced care directive limiting ICU admission or with limited life expectancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
S
Sanne Ter Horst, MD
CONTACT
S
Sanne Ter Horst, MD
CONTACT
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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