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

NCT ID: NCT01682590

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31

Brief 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.

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.

Conditions

Septic Shock; Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Early initiation of RRT

Start of RRT within a maximum of 12 hours after randomisation.

Group Type: EXPERIMENTAL

Renal Remplacement Therapy

Intervention Type: PROCEDURE

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.

Deferred RRT

Start of RRT between 48 and 60 hours after randomisation.

Group Type: ACTIVE_COMPARATOR

Renal Remplacement Therapy

Intervention Type: PROCEDURE

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.

Interventions

Renal Remplacement Therapy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre QUENOT

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire Dijon

Saber Davide BARBAR

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

CH Avignon

Avignon, , France

CH Belfort

Belfort, , France

CHU Besançon

Besançon, , France

CH de BOURG-EN-BRESSE

Bourg-en-Bresse, , France

CHU Caen

Caen, , France

CHU Clermont-Ferrand

Clermont-Ferrand, , France

CH Dieppe

Dieppe, , France

CHU Dijon

Dijon, , France

CH Sud Essonne - Site Etampes

Étampes, , France

Hôpital Raymond-Poincaré GARCHES (AP-HP)

Garches, , France

CHU Grenoble

Grenoble, , France

CH de LA ROCHE sur YON

La Roche-sur-Yon, , France

Groupe Hospitalier de l'institut Catholique de LILLE

Lille, , France

CHU de Lyon

Lyon, , France

CHU Montpellier

Montpellier, , France

CHU Lapeyronie

Montpellier, , France

CHG Mulhouse

Mulhouse, , France

CHU Nancy Brabois

Nancy, , France

CHU Nîmes

Nîmes, , France

CHR d'Orléans

Orléans, , France

Hôpital Cochin

Paris, , France

HOPITAL BICHAT Claude-Bernard

Paris, , France

CH Périgueux

Périgueux, , France

CHU Lyon Sud

Pierre-Bénite, , France

CHU de Strasbourg - Nouvel hôpital civil

Strasbourg, , France

CHR Metz

Thionville, , France

CHRU Tours

Tours, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 24998258 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36416787 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30304656 (View on PubMed)

Other Identifiers

Quenot IDEAL-ICU

Identifier Type: -

Identifier Source: org_study_id