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

Last updated: November 26, 2018
Sponsor: Centre Hospitalier Universitaire Dijon
Overall Status: Terminated

Phase

3

Condition

Nephropathy

Sepsis And Septicemia

Kidney Failure

Treatment

N/A

Clinical Study ID

NCT01682590
Quenot IDEAL-ICU
  • Ages > 18
  • All Genders

Study 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 septic shock.

Eligibility Criteria

Inclusion

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 forinclusion. Septic shock is defined as severe sepsis with at least 2 to 4 "SIRS" criteria andpersistent 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 appropriatelyinformed about the study. In case of temporary incapacity of the patient to sign, theconsent form can be signed by a surrogate.

Exclusion

Exclusion Criteria: Patients presenting any of the following criteria will not be eligible for inclusion in thestudy:

  1. Patients with chronic renal at dialysis.

  2. Patients presenting acute renal failure of type obstructive and patients alreadypresenting 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 prognosisof patients.

Study Design

Total Participants: 500
Study Start date:
July 01, 2012
Estimated Completion Date:

Study 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.

Connect with a study center

  • CH Avignon

    Avignon, 84000
    France

    Site Not Available

  • CH Belfort

    Belfort, 90000
    France

    Site Not Available

  • CHU Besançon

    Besançon, 25000
    France

    Site Not Available

  • CH de BOURG-EN-BRESSE

    Bourg-en-Bresse, 01012
    France

    Site Not Available

  • CHU Caen

    Caen, 14003
    France

    Site Not Available

  • CH de Chalon-Sur-Saône

    Chalon-Sur-Saône, 71100
    France

    Site Not Available

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63100
    France

    Site Not Available

  • CH Colmar

    Colmar, 68000
    France

    Site Not Available

  • CH Dieppe

    Dieppe, 76200
    France

    Site Not Available

  • CHU Dijon

    Dijon, 21000
    France

    Site Not Available

  • CH Sud Essonne - Site Etampes

    Etampes, 91 150
    France

    Site Not Available

  • Hôpital Raymond-Poincaré GARCHES (AP-HP)

    Garches, 92380
    France

    Site Not Available

  • CHU Grenoble

    Grenoble, 38043
    France

    Site Not Available

  • CH de LA ROCHE sur YON

    La Roche sur Yon, 85000
    France

    Site Not Available

  • Le Kremlin-Bicetre (Aphp)

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • Groupe Hospitalier de l'institut Catholique de LILLE

    Lille, 59160
    France

    Site Not Available

  • CHU de Lyon

    Lyon, 69000
    France

    Site Not Available

  • CH Melun

    Melun, 77000
    France

    Site Not Available

  • CHU Lapeyronie

    Montpellier, 34295
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 34000
    France

    Site Not Available

  • CHG Mulhouse

    Mulhouse, 68100
    France

    Site Not Available

  • CHU Nancy Brabois

    Nancy, 54000
    France

    Site Not Available

  • CHU Nîmes

    Nîmes, 30000
    France

    Site Not Available

  • CHR d'Orléans

    Orleans, 45100
    France

    Site Not Available

  • HOPITAL BICHAT Claude-Bernard

    Paris, 75018
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • CHU Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • CHU Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • CH Périgueux

    Périgueux, 24019
    France

    Site Not Available

  • CHU Reims

    Reims, 51100
    France

    Site Not Available

  • CHU de Strasbourg - Nouvel hôpital civil

    Strasbourg, 67000
    France

    Site Not Available

  • CHR Metz

    Thionville, 57100
    France

    Site Not Available

  • CHRU Tours

    Tours,
    France

    Site Not Available

  • CH Vesoul

    Vesoul, 70000
    France

    Site Not Available

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