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Timing of dialysis in septic shock: early vs. delayed – study halted early

NCT ID NCT01682590

Disease control Sponsor: Centre Hospitalier Universitaire Dijon 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at 500 adults with septic shock and severe acute kidney injury to see if starting dialysis early (within 12 hours) or waiting (48-60 hours) affected survival at 90 days. The trial was terminated early, so the results are not conclusive. The goal was to find the best timing for dialysis in critically ill patients.

What this could mean

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

Active substance
dialysis (renal replacement therapy)
What this could lead to
If successful, this could help doctors decide the best time to start dialysis for patients with septic shock and kidney failure, potentially improving survival.
What could go wrong
The trial was terminated early, so results are limited. It is unclear whether early or delayed dialysis is better, and findings may not apply to all patients.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

500 people

The number who actually took part.

Start date

Jul 2012

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: Adults (males or females, age \>18 years) with septic shock who develop acute renal failure (as defined by the "Failure" stage of the RIFLE classification) will be eligible for inclusion. Septic shock is defined as severe sepsis with at least 2 to 4 "SIRS" criteria and persistent hypotension despite adequate vascular filling and need vaso-active drugs. SIRS is defined as the simultaneous presence of at least 2 of the following criteria : * Body temperature ≥ 38°C ou ≤ 36°C * Heart rate ≥ 90 bpm * Respiratory rate ≥ 20/mn or PaCO2 ≤ 32 mmHg * Leucocytes ≥ 12,000/mm3 or ≤ 4,000/mm3 or \>10% immature forms. Acute renal insufficiency is defined as the "failure" stage of the RIFLE classification, i.e. the presence of at least one of the following criteria: * Increased creatinine x 3 times the baseline value * Oliguria \< 0.3 ml/kg/h for 12 hours * Anuria (diuresis \< 100ml) for at least 12 hours All patients are required to provide informed consent after having been appropriately informed about the study. In case of temporary incapacity of the patient to sign, the consent form can be signed by a surrogate. Exclusion Criteria: Patients presenting any of the following criteria will not be eligible for inclusion in the study: 1. Patients with chronic renal at dialysis. 2. Patients presenting acute renal failure of type obstructive and patients already presenting emergency criteria for immediate hemodialysis at the time of randomization (i.e. hyperkalemia \>6.5 mmol/L or pH\<7.15 or pulmonary oedema by fluid overload) 3. Patients already had hemodialysis before their arrival in the intensive care unit 4. Pregnant women. 5. Moribund patients whose life expectancy is less than 24 hours 6. Patients unlikely to survive to 28 days because of uncontrollable comorbidities (e.g. cardiac, pulmonary or hepatic disease at the terminal stage, hepatorenal syndrome, uncontrolled cancer, severe post-anorexic encephalopathy…) 7. Patients with advance directives indicating their wish not to be resuscitated. 8. Patients under legal guardianship. 9. Patients participing in another interventional study that may influence the prognosis of patients.

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Conditions

The condition(s) this trial relates to.

acute kidney injury toxic shock syndrome

As listed by the trial registrant

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

Acute renal failure (as defined by the "failure" stage of the rifle classification) Septic shock

Contacts and locations

Locations

  • CH Avignon

    Avignon, 84000, France

  • CH Belfort

    Belfort, 90000, France

  • CH Dieppe

    Dieppe, 76200, France

  • CH Périgueux

    Périgueux, 24019, France

  • CH Sud Essonne - Site Etampes

    Étampes, 91 150, France

  • CH de BOURG-EN-BRESSE

    Bourg-en-Bresse, 01012, France

  • CH de LA ROCHE sur YON

    La Roche-sur-Yon, 85000, France

  • CHG Mulhouse

    Mulhouse, 68100, France

  • CHR Metz

    Thionville, 57100, France

  • CHR d'Orléans

    Orléans, 45100, France

  • CHRU Tours

    Tours, France

  • CHU Besançon

    Besançon, 25000, France

  • CHU Caen

    Caen, 14003, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63100, France

  • CHU Dijon

    Dijon, 21000, France

  • CHU Grenoble

    Grenoble, 38043, France

  • CHU Lapeyronie

    Montpellier, 34295, France

  • CHU Lyon Sud

    Pierre-Bénite, 69495, France

  • CHU Montpellier

    Montpellier, 34000, France

  • CHU Nancy Brabois

    Nancy, 54000, France

  • CHU Nîmes

    Nîmes, 30000, France

  • CHU de Lyon

    Lyon, 69000, France

  • CHU de Strasbourg - Nouvel hôpital civil

    Strasbourg, 67000, France

  • Groupe Hospitalier de l'institut Catholique de LILLE

    Lille, 59160, France

  • HOPITAL BICHAT Claude-Bernard

    Paris, 75018, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Raymond-Poincaré GARCHES (AP-HP)

    Garches, 92380, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.