Personalized IV fluid care for sepsis in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.