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One-Size-Fits-All sepsis care challenged: new study tests tailored fluids

NCT ID NCT07009665

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving fluids and blood pressure medicines based on each patient's heart response can improve sepsis care. 188 adults with sepsis in the emergency department will be randomly assigned to either personalized treatment or standard care. The goal is to see if the personalized approach uses less fluid, starts medicines earlier, and leads to safer recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IV fluids and vasopressors
What this could lead to
If successful, this could lead to safer, more effective sepsis treatment by tailoring fluids to each patient's heart response, reducing complications like fluid overload.
What could go wrong
This is a small, early-phase study (188 participants) at one hospital. The personalized approach may not improve outcomes or could be harder to implement in busy ERs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Medical Centre Groningen

    RECRUITING

    Groningen, Provincie Groningen, 9713GZ, Netherlands

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