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Timing is everything: fluid challenge evaluation in septic shock

NCT ID NCT02116413

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 145 patients with septic shock to see if the time when doctors check if a fluid bolus worked changes the results. Patients received 500 ml of fluid over 10 minutes. The study found that some patients who seemed to respond right away were no longer responding 20 minutes later. This helps doctors understand the best time to evaluate treatment effectiveness.

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.

Participants

145 people

The number who actually took part.

Start date

May 2014

Finished

Jan 2016

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.

Who is studied

The study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria: * oliguria \<0.5 ml / kg / h for at least 2h * skin mottling * Arterial Lactate \> 2 mmol / l * SvcO2 \<70% or SvO2 \<65% * Patient on noradrenaline. Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate\> 4 mmol / l or organ dysfunction.

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: * The patient has given his/hers consent or the patient is in an emergency situation (commitment to obtain the consent of the patient as soon as his/her condition permits) * Patient affiliated or beneficiary of a health insurance plan * Patient with septic shock: proven or suspected infection associated with hypotension or lactate\> 4 mmol / l or organ dysfunction. Hypotension despite fluid resuscitation of 20 to -40 ml / kg. * Patient under controlled mechanical ventilation * Patient requiring vascular filling according to the following criteria: * oliguria \<0.5 ml / kg / h for at least 2h * skin mottling * Arterial Lactate \> 2 mmol / l * SvcO2 \<70% or SvO2 \<65% * Patient on noradrenaline. Exclusion Criteria: * The patient is has in another interventional study that might change the results of this study within the past 3 months * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * The patient is pregnant, parturient, or breastfeeding * Valvular pathology: grade III and IV aortic or mitral insufficiency * Non sinus electrocardiogram * Non-echogenic patient * Patient with any spontaneous breathing * Moribund patient

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

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

Septic shock

Contacts and locations

Locations

  • APHM - Hôpital Nord

    Marseille, 13915, France

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029, France

  • CHU d'Amiens - Hôpital Nord

    Amiens, 80054, France

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon, 25030, France

  • CHU de Caen - Hôpital Côte de Nacre

    Caen, 14033, France

  • CHU de Clermont Ferrand - Hôpital Estaing

    Clermont-Ferrand, 63003, France

  • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

    Clermont-Ferrand, 63003, France

  • CHU de Nantes - Hôpital Guillaume et René Laennec

    Nantes, 44093, France

  • CHU de Nice - Hôpital St-Roch

    Nice, 06001, France

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