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Septic ShockPhase 3IDEAL-ICUNCT01682590

I.D.E.A.L.-I.C.U. (Initiation of Dialysis EArly Versus deLayed in Intensive Care Unit)

A Phase 3 study testing Renal Remplacement Therapy in people with Septic Shock and Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification), run by Centre Hospitalier Universitaire Dijon at 27 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Renal Remplacement Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
27 sitesFrance
Study dates
Jul 2012to Oct 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • Patients presenting any of the following criteria will not be eligible for inclusion in the study:
  • Patients with chronic renal at dialysis.
  • 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)
  • Patients already had hemodialysis before their arrival in the intensive care unit
  • Pregnant women.
  • Moribund patients whose life expectancy is less than 24 hours
Show all 10Show fewer
  • 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…)
  • Patients with advance directives indicating their wish not to be resuscitated.
  • Patients under legal guardianship.
  • Patients participing in another interventional study that may influence the prognosis of patients.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

France27 sites

  • CH Avignon

    Avignon, 84000

  • CH Belfort

    Belfort, 90000

  • CHU Besançon

    Besançon, 25000

  • CH de BOURG-EN-BRESSE

    Bourg-en-Bresse, 01012

  • CHU Caen

    Caen, 14003

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63100

  • CH Dieppe

    Dieppe, 76200

  • CHU Dijon

    Dijon, 21000

  • CH Sud Essonne - Site Etampes

    Étampes, 91 150

  • Hôpital Raymond-Poincaré GARCHES (AP-HP)

    Garches, 92380

  • CHU Grenoble

    Grenoble, 38043

  • CH de LA ROCHE sur YON

    La Roche-sur-Yon, 85000

  • Groupe Hospitalier de l'institut Catholique de LILLE

    Lille, 59160

  • CHU de Lyon

    Lyon, 69000

  • CHU Montpellier

    Montpellier, 34000

  • CHU Lapeyronie

    Montpellier, 34295

  • CHG Mulhouse

    Mulhouse, 68100

  • CHU Nancy Brabois

    Nancy, 54000

  • CHU Nîmes

    Nîmes, 30000

  • CHR d'Orléans

    Orléans, 45100

  • Hôpital Cochin

    Paris, 75014

  • HOPITAL BICHAT Claude-Bernard

    Paris, 75018

  • CH Périgueux

    Périgueux, 24019

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Strasbourg - Nouvel hôpital civil

    Strasbourg, 67000

  • CHR Metz

    Thionville, 57100

  • CHRU Tours

    Tours

Other trials in France

About this study

Official title: Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial

The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.

Read the detailed description

Acute renal failure is one of the most feared complications of septic shock and occurs in 51% of patients with these conditions. Mortality at 3 months ranges from 36% to 60%. To date, these exists no consensus regarding the optimal time to initiate renal remplacement therapy (RRT). Retrospective and observational studies have suggested that early initiation of RRT could help to improve prognosis in these patients. Therefore, we aim to investigate wether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the "failure" stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT (48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure.

Secondary objectives include: to compare the impact of the two RRT strategies on 28, 180 et 360 day mortality, duration of mechanical ventilation, duration of RRT, duration of ICU stay and duration of overall hospital stay. In addition, quality of life at 90 and 360 days will be evaluated using the EQ5D questionnaire. Tolerance of both strategies will be compared in terms of metabolic disorders, arrhythmias, pulmonary oedema by overload, hypotension, hemorrhagic complications, and dependence on RRT at hospital discharge.

Being tested
Renal Remplacement Therapy
Keywords
septic shock; acute renal failure; renal remplacement therapy; mortality; intensive care; critical care; acute kidney injury
Medical subject headings
Shock, Septic, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Remplacement TherapyProcedure or surgery

    Investigators of each center will have the choice of the RRT technique based on their usual practice: intermittent hemodialysis, intermittent hemodiafiltration, continuous hemodialysis, continuous hemofiltration, continuous hemodiafiltration (typically the continuous techniques in the acute phase, followed by intermittent techniques after stabilization).

    In case of life threatening conditions within the 48 hours after randomisation (hyperkalemia, metabolic acidosis or pulmonary edema) the RRT will be initiated as soon as possible.

    In case of improvement of renal function within the 48 hours after randomisation (defined as the return of spontaneous urine output > 1000ml/24 hr or >2000ml/24hr with diuretics), RRT is not mandatory.

Study groups in NCT01682590
Study groupRoleWhat they receive
Early initiation of RRTExperimentalStart of RRT within a maximum of 12 hours after randomisation.
Receives: Procedure: Renal Remplacement Therapy
Deferred RRTActive comparatorStart of RRT between 48 and 60 hours after randomisation.
Receives: Procedure: Renal Remplacement Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    To investigate whether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the "failure" stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT (48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure.

    Measured: 90 days

Secondary outcomes (1)

  1. Comparison of the tolerance and evaluation quality of life

    Secondary objectives include: to compare the impact of the two RRT strategies on 28, 180 and 360 day mortality, duration of mechanical ventilation, duration of RRT, duration of ICU stay and duration of overall hospital stay. In addition, quality of life at 90 and 360 days will be evaluated using the EQ5D questionnaire. Tolerance of both strategies will be compared in terms of metabolic disorders, arrhythmias, pulmonary oedema by overload, hypotension, hemorrhagic complications, and dependence on RRT at hospital discharge.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
To investigate whether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the"failure" stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT(48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01682590
Sponsor's protocol ID
Quenot IDEAL-ICU
Acronym
IDEAL-ICU
Status last verified
Feb 2026
First submitted
10 Sep 2012
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Barbar SD, Binquet C, Monchi M, Bruyere R, Quenot JP. Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.

    PubMed 24998258

  • Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.

    PubMed 30304656

  • Barbar SD, Dargent A, Quenot JP. Timing of Renal-Replacement Therapy in Acute Kidney Injury and Sepsis. N Engl J Med. 2019 Jan 24;380(4):399. doi: 10.1056/NEJMc1815142. No abstract available.

    PubMed 30673539

  • Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

    PubMed 36416787

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Renal Remplacement Therapy in people with Septic Shock and Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification), run by Centre Hospitalier Universitaire Dijon at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01682590, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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