Fluid Management and Individualized Resuscitation in Sepsis

NCT07009665 | Recruiting DMC

• 1 other identifier: NL84833.099.24
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sepsis; Shock; Personalized medicine; emergency medicine; critical care; fluid resuscitation; fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• The volume of IV fluids in ml administered within the first three hours after study enrolment.

  The primary endpoint is the volume of IV fluids in ml administered within the first three hours after study enrolment.

  Up to three hours, after study enrolment.

Secondary Outcomes (22)

• Length-of-stay in hospital/intensive care unit (ICU)

  Until hospital discharge, an average of 2 weeks

• New onset organ failure

  Up to 48 hours after hospitalization

• Fluid balance

  Up to three hours after hospitalization

• Fluid resuscitation

  Up to 7 days after hospitalization

• Time to recovery of hemodynamic stability

  The time interval from hospital admission until hemodynamic stability, measured in hours.

Other Outcomes (5)

• Cost-effectiveness

  Up to 30 days after hospitalization

• Starling SV monitor trends

  Up to three hours after hospitalization

• Hemodynamic parameter trends

  Up to three hours after hospitalization

Study Arms (2)

Personalized SV-Guided Resuscitation

EXPERIMENTAL

Other: Personalized SV-guided resuscitation

Standard Care Resuscitation

ACTIVE COMPARATOR

Other: Standard Care Resuscitation

Interventions

Personalized SV-guided resuscitation OTHER

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.

Personalized SV-Guided Resuscitation

Standard Care Resuscitation OTHER

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).

Standard Care Resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years of age);
• 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 according to the physician's judgement upon arrival to the ED, based the presence of an acute phase response not due to an alternative non-infectious cause (i.e., body temperature \< 36°C or \>38°C, leukocyte count \> 12 x109/L or C-reactive protein \> 50 mg/L), and/or on symptoms suggestive for an infection (e.g. productive cough, dyspnea, dysuria, pollakisuria, abdominal pain, erythema)
• Need for hemodynamic resuscitation, based on any of the following (first measurement at ED arrival \[triage\]):
• Mean arterial pressure (MAP) \< 70 mmHg
• Systolic blood pressure (SBP) \< 90 mmHg or a SBP decrease \>40 mmHg
• Lactate \> 4.0 mmol/L
• Shock index\* \> 0.9
• Enrolled in study within one hour after ED arrival

You may not qualify if:

• Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, or injury from burn or trauma, diabetic ketoacidosis, hyper-osmolarity syndrome, pancreatitis
• Known aortic insufficiency, aortic abnormalities, or intraventricular heart defect, such as ventral septal defect or atrial septal defect
• Known advanced heart failure - meaning NYHA IV functional class HF, on waiting list for heart transplant, LVAD recipient or chronic inotrope use.
• Known end-stage kidney disease (dialysis-dependent CKD stage 5 or eGFR \<15 mL/min/1.73 m²)
• Decompensated liver cirrhosis at ED admission (e.g., ascites, hepatic encephalopathy, or variceal bleeding)
• Hemodynamic instability due to active bleeding
• Patient has received \>1 liter of IV fluid prior to study randomization
• Requires immediate surgery
• Transfer from another hospital after initiation of therapy (a.o. referred by another hospital ICU) or another in-hospital setting
• Pregnant women
• Trauma patients
• Suspected intra-abdominal hypertension, based on the presence of portal hypertension (i.e. presence of ascites due to liver cirrhosis, esophageal varices or as measured by Doppler ultrasound)
• Inability to obtain IV access
• Patient uncouples from treatment algorithm
• Patient should be excluded based on the opinion of the Clinician/Investigator

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Related Publications (1)

• Ter Horst S, Ter Avest E, van Everdink J, van Meurs M, Olgers TJ, Vos JJ, Damman K, Ter Maaten JC, Bouma HR. FLUid management and InDividualized resuscitation in Sepsis (FLUIDS)-A Study protocol for a single-centre, open-label, randomized clinical trial. PLoS One. 2025 Dec 19;20(12):e0338504. doi: 10.1371/journal.pone.0338504. eCollection 2025.

  PMID: 41417807 DERIVED

MeSH Terms

Conditions

Sepsis; Shock

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sanne Ter Horst, MD

CONTACT

+31 6 25650284 (FLUIDS phone); s.ter.horst@umcg.nl

Sanne Ter Horst, MD

CONTACT

s.ter.horst@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, EuCP (PI)

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

NL (1)