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Can less fluid be better for septic shock patients?

NCT ID NCT04947904

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether carefully limiting fluids given for non-emergency reasons (like nutrition or drug dilution) could reduce fluid overload in intensive care patients with septic shock. 50 patients were randomly assigned to either the standard approach or a restrictive fluid strategy. The goal was to see if this approach could improve fluid balance by day 5.

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

50 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2023

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 to 85 years

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: * Patient suffering from an infection already documented or suspected * Patient with organ dysfunction defined as an acute change in SOFA score ≥ 2 points * Patient with refractory hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mm Hg in spite of resuscitation with an adequate volume of intravenous fluids (according to the recommendations of the Surviving Sepsis campaign). The treatment by vasopressor must have been started less than 24 hours before inclusion and randomization. * Patient with hyperlactatemia (blood lactate \> 2 mmol / L). This criterion must be fulfilled at least once for the purpose of the diagnosis within the 24 hours preceding inclusion and randomization. * Patient or close relative / legal representative / family member / curator / tutor must have given written informed consent and signed the consent form for the patient included in an emergency situation * Patient must be covered by a health insurance scheme. * Adult patient (≥18 years) under 85 years old (\< 85). Exclusion Criteria: * Patient who has had a previous episode of septic shock requiring vasopressor administration or mechanical ventilation or renal replacement therapy during the current ICU stay. * A patient whose life expectancy is shortened due to his/her initial health condition or a moribund patient whose life expectancy is less than 48 hours or whose decision to limit comprehensive care was made before including the patient. * Patient who has had a recent cardiac arrest (during current hospital stay) * Patient requiring emergency renal-replacement therapy (hyperkalemia \[potassium \> 6.5 mmol/l\] refractory to medical treatment and/or metabolic acidosis \[pH \<7.15 and partial pressure of carbon dioxide (pCO2) \<45 mmHg\] refractory to medical treatment and/or pulmonary edema in anuric patients who do not respond to diuretic therapy). * Patient with KDIGO 3 acute kidney injury and likely to require renal-replacement therapy within the next 24 hours, as determined by the patient's clinician in charge * Patients with end-stage chronic renal failure or patients already undergoing chronic dialysis * Severely malnourished patient in whom nutritional support is an emergency procedure (body mass index \<18 kg / m2) * Patient participating in or having participated in an interventional study with similar patient outcome in the previous 3 months. * Patient in an exclusion period determined by another study. * Patient under legal protection. * Pregnant patient (positive serum pregnancy test).

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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.

Contacts and locations

Locations

  • CHU de DIJON

    Dijon, 21000, France

  • CHU de Montpellier

    Montpellier, 34000, France

  • Centre Hospitalier d'Alès

    Alès, 30100, France

  • Nimes University Hospital

    Nîmes, 30000, France

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