NCT07009665

Fluid Management and Individualized Resuscitation in Sepsis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Sepsis
• Shock
• Personalized Medicine
• Emergency Medicine
• Critical Care, Fluid Resuscitation
• Fluid Responsiveness

Interventions

Type	Name	Description
OTHER	Personalized SV-guided resuscitation	Participants will receive an IV fluid bolus directly after inclusion. Next, measurement of the cardiac output change in response to the fluid bolus by the Starling SV will be used to determine fluid responsiveness. Vital parameters and fluid responsiveness will be used to guide hemodynamic resuscitation, consisting of IV fluids and/or vasopressors, during the first 3 hours.
OTHER	Standard Care Resuscitation	In the control group, IV fluid and vasopressor administration will be determined at the discretion of the physician and in accordance with currently available guidelines (e.g. Sepsis Surviving Campaign).

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-06-06
• Last updated: 2025-12-19

Locations

1 site across 1 country: Netherlands