Can less fluid be better for septic shock patients?
NCT ID NCT04947904
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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50 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Feb 2023
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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CHU de DIJON
Dijon, 21000, France
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CHU de Montpellier
Montpellier, 34000, France
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Centre Hospitalier d'Alès
Alès, 30100, France
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Nimes University Hospital
Nîmes, 30000, France
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Other studies related to the condition(s) this trial covers.
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