Personalized IV fluid care for sepsis in the emergency department
Fluid Management and Individualized Resuscitation in Sepsis
This study will test whether giving IV fluids based on each adult's heart response helps people with suspected sepsis in the emergency department recover more safely than standard fluid care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT07009665 on ClinicalTrials.gov |
What this trial studies
This is a randomized comparison at the University Medical Centre Groningen enrolling 188 adults who present to the ED with suspected sepsis and need hemodynamic resuscitation. All participants receive IV fluids, and they are randomized to either a personalized approach that guides fluid delivery using stroke-volume response or to standard care resuscitation. Enrollment must occur within one hour of ED arrival and treatment decisions are made in real time at the bedside. The trial focuses on whether tailoring fluids to physiologic response reduces complications such as fluid overload while supporting blood pressure and organ perfusion.
Who should consider this trial
Good fit: Adults (≥18 years) who arrive at the UMCG ED with suspected or confirmed infection and signs of hemodynamic compromise (e.g., MAP <70 mmHg, SBP <90 mmHg or drop >40 mmHg, lactate >4.0 mmol/L, or shock index >0.9) and who can be enrolled within one hour of arrival are ideal candidates.
Not a fit: Patients who do not require hemodynamic resuscitation, who have an alternative non-infectious cause for their presentation, who present outside the enrollment window, or who are treated at other hospitals are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reduce fluid overload and related complications while improving blood pressure support and organ perfusion for patients with sepsis.
How similar studies have performed: Previous trials of fluid-responsiveness guided resuscitation have shown mixed but promising results in selected settings, so applying stroke-volume–guided fluids in the ED builds on existing but not yet definitive evidence.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 * Not able to commence treatment protocol within 1 hour after randomization * Potential ICU-admission unwanted by advanced care directive (e.g., limited life expectancy)
Where this trial is running
Groningen, Provincie Groningen
- University Medical Centre Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Sanne Ter Horst, MD
- Email: s.ter.horst@umcg.nl
- Phone: +31 6 25650284 (FLUIDS phone)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.