Clinical trial NCT07009665: Fluid Management and Individualized Resuscitation in Sepsis
Official title: Fluid Management and Individualized Resuscitation in Sepsis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 174 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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
* Known major lower extremity amputation (proximal to the ankle joint)
* 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
* Not able to commence treatment protocol within 1 hour after randomization
* Potential ICU-admission unwanted by advanced care directive (e.g., limited life expectancy)

Primary outcomes:
measure: The volume of IV fluids in ml administered within the first three hours after study enrolment.
timeFrame: Up to three hours, after study enrolment.
Secondary outcomes:
measure: Length-of-stay in hospital/intensive care unit (ICU)
timeFrame: Until hospital discharge, an average of 2 weeks
measure: New onset organ failure
timeFrame: Up to 48 hours after hospitalization
measure: Fluid balance
timeFrame: Up to three hours after hospitalization
measure: Fluid resuscitation
timeFrame: Up to 7 days after hospitalization
measure: Time to recovery of hemodynamic stability
timeFrame: The time interval from hospital admission until hemodynamic stability, measured in hours.
measure: Pre-tibial edema development
timeFrame: Up to 48h after hospitalization
measure: Fluid overload at three hours (assessed by Point-of-Care Ultrasound)
timeFrame: Up to three hours after hospitalization
measure: Fluid overload at 24h (assessed by Point-of-Care Ultrasound)
timeFrame: Up to 24h after hospitalization
measure: Loop diuretic use
timeFrame: Up to 7 days after hospitalization
measure: Decompensated heart failure
timeFrame: Up to 7 days after hospitalization
measure: Respiratory insufficiency and acute respiratory distress syndrome (ARDS)
timeFrame: Up to 7 days after hospitalization
measure: Acute Kidney Injury (AKI within 48 hours)
timeFrame: Up to 48 hours after hospitalization
measure: Acute Kidney Injury (AKI within seven days)
timeFrame: Up to 7 days after hospitalization
measure: Change in Serum Creatinine Levels (from Baseline to 48 Hours)
timeFrame: From baseline to 48 hours
measure: Change in Serum Creatinine Levels (from baseline to 7 days)
timeFrame: From baseline to 7 days
measure: Requirement for renal replacement therapy (RRT) within 7 days
timeFrame: Up to 7 days after hospitalization
measure: Requirement for renal replacement therapy (RRT) within 30 days
timeFrame: Up to 30 days after hospitalization
measure: Major Adverse Cardiac Event (MACE)
timeFrame: Up to 30 days
measure: Vasopressor initiation within three hours
timeFrame: Up to three hours
measure: Vasopressor initiation within 7 days
timeFrame: Up to 7 days
measure: Time to vasopressor initiation
timeFrame: The time interval from hospital admission until the initiation of vasopressor therapy, measured in hours.
measure: All-cause mortality (up to 30 days):
timeFrame: Time from hospital admission until death from any cause, up to 30 days
Other outcomes:
measure: Cost-effectiveness
timeFrame: Up to 30 days after hospitalization
measure: Starling SV monitor trends
timeFrame: Up to three hours after hospitalization
measure: Hemodynamic parameter trends
timeFrame: Up to three hours after hospitalization
measure: Photoplethysmographic (PPG) waveform trends
timeFrame: Up to three hours after hospitalization
measure: Electrocardiography (ECG) waveform trends
timeFrame: Up to three hours after hospitalization
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
References: