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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01682590
First received: September 10, 2012
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Septic Shock
Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification)
Procedure: Renal Remplacement Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Comparison of the tolerance and evaluation quality of life [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 864
Study Start Date: July 2012
Arms Assigned Interventions
Experimental: Early initiation of RRT
Start of RRT within a maximum of 12 hours after randomisation.
Procedure: 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.

Active Comparator: Deferred RRT
Start of RRT between 48 and 60 hours after randomisation.
Procedure: 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682590

Contacts
Contact: Jean-Pierre QUENOT 3 80 29 36 85 ext 33 jean-pierre.quenot@chu-dijon.fr
Contact: Saber Davide BARBAR 4 66 68 33 20 ext 33 saber.barbar@chu-nimes.fr

Locations
France
CH Avignon Recruiting
Avignon, France, 84000
Contact: Laurence DELAPIERRE    04 32 75 34 68 ext 33    ldelapierre@ch-avignon.fr   
CH Belfort Recruiting
Belfort, France, 90000
Contact: Julio BADIE    3 84 98 50 69 ext 33    mfeissel@chbm.fr   
Principal Investigator: Julio BADIE         
CHU Besançon Recruiting
Besançon, France, 25000
Contact: Gilles CAPELLIER    3 81 66 82 59 ext 33    gilles.capellier@univ-fcomte.fr   
Principal Investigator: Gilles CAPELLIER         
CHU Besançon Recruiting
Besançon, France, 25000
Contact: Gilles BLASCO    3 81 66 81 66 ext 33    gblasco@chu-besancon.fr   
Principal Investigator: Gilles BLASCO         
CH de BOURG-EN-BRESSE Recruiting
Bourg-en-Bresse, France, 01012
Contact: Rémi BRUYERE         
CHU Caen Recruiting
Caen, France, 14003
Contact: Damien DU CHEYRON    02 31 06 47 16 ext 33    ducheyron-d@chu-caen.fr   
CH de Chalon-Sur-Saône Withdrawn
Chalon-Sur-Saône, France, 71100
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63100
Contact: Jean-Michel CONSTANTIN    04 73 75 05 01 ext 33    jmconstantin@chu-clermontferrand.fr   
CH Dieppe Recruiting
Dieppe, France, 76200
Contact: Jean-Philippe RIGAUD    2 32 14 75 50 ext 33    jrigaud@ch-dieppe.fr   
Principal Investigator: Jean-Philippe RIGAUD         
CHU Dijon Recruiting
Dijon, France, 21000
Contact: Jean-Pierre QUENOT    3 80 29 36 85 ext 33    jean-pierre.quenot@chu-dijon.fr   
Principal Investigator: Jean-Pierre QUENOT         
DIJON Général Withdrawn
Dijon, France, 21000
CH Sud Essonne - Site Etampes Recruiting
Etampes, France, 91 150
Contact: Shidasp SIAMI    01 60 80 79 40 ext 33    shidasp.siami@ch-sudessonne.fr   
Hôpital Raymond-Poincaré GARCHES (AP-HP) Recruiting
Garches, France, 92380
Contact: Djillali ANNANE    1 47 01 07 86 ext 33    djillali.annane@rpc.aphp.fr   
Principal Investigator: Djillali ANNANE         
CHU Grenoble Recruiting
Grenoble, France, 38043
Contact: Carole SCHWEBEL       CSchwebel@chu-grenoble.fr   
CH de LA ROCHE sur YON Recruiting
La Roche sur Yon, France, 85000
Contact: Jean REIGNIER       jean.reignier@chd-vendee.fr   
Principal Investigator: Jean REIGNIER         
Groupe Hospitalier de l'institut Catholique de LILLE Recruiting
Lille, France, 59160
Contact: Thierry VAN DER LINDEN    3 20 22 50 26 ext 33    vanderlinden.thierry@ghicl.net   
Principal Investigator: Thierry VAN DER LINDEN         
CHU de Lyon Recruiting
Lyon, France, 69000
Contact: Laurent ARGAUD    4 72 11 00 15 ext 33    laurent.argaud@chu-lyon.fr   
Principal Investigator: Laurent ARGAUD         
CH Melun Withdrawn
Melun, France, 77000
CHU Montpellier Recruiting
Montpellier, France, 34000
Contact: Samir JABER    4 67 33 72 71 ext 33    s-jaber@chu-montpellier.fr   
Principal Investigator: Samir JABER         
CHU Lapeyronie Recruiting
Montpellier, France, 34295
Contact: Kada KLOUCHE    03 46 73 84 41 ext 33    k-klouche@chu-montpellier.fr   
CHG Mulhouse Recruiting
Mulhouse, France, 68100
Contact: Philippe GUIOT    3 89 64 61 26 ext 33    guiotp@ch-mulhouse.fr   
Principal Investigator: Philippe GUIOT         
CHU Nancy Brabois Recruiting
Nancy, France, 54000
Contact: Bruno LEVY       b.levy@chu-nancy.fr   
Principal Investigator: Bruno LEVY         
CHU Nîmes Recruiting
Nîmes, France, 30000
Contact: Saber Davide BARBAR    3 80 29 36 85 ext 33    saber.barbar@chu-nimes.fr   
Principal Investigator: Saber Davide BARBAR         
CHR d'Orléans Recruiting
Orleans, France, 45100
Contact: Thierry BOULAIN    02 38 51 44 46 ext 33    thierry.boulain@chr-orleans.fr   
HOPITAL BICHAT Claude-Bernard Recruiting
Paris, France, 75018
Contact: Lila BOUADMA       lila.bouadma@bch.aphp.fr   
Hôpital Saint Joseph (APHP) Withdrawn
Paris, France, 75014
Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Jonathan ROUCHE    01 58 41 25 17 ext 33    jonathan.rouche@cch.aphp.fr   
CHU Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Julien BOHE       julien.bohe@chu-lyon.fr   
Principal Investigator: Julien BOHE         
CH Périgueux Recruiting
Périgueux, France, 24019
Contact: Yannick MONSEAU    05 53 45 26 59 ext 33    yannick.monseau@ch-perigueux.fr   
CHU Reims Withdrawn
Reims, France, 51100
CHU de Strasbourg - Nouvel hôpital civil Recruiting
Strasbourg, France, 67000
Contact: Ferhat MEZIANI         
Principal Investigator: Ferhat MEZIANI         
Hôpital de Hautepierre - CHU Strasbourg Withdrawn
Strasbourg, France, 67000
CHR Metz Recruiting
Thionville, France, 57100
Contact: Guillaume LOUIS    6 47 93 74 69 ext 33    gus_louis@yahoo.fr   
Principal Investigator: Guillaume LOUIS         
CHRU Tours Recruiting
Tours, France
Contact: Emmanuelle MERCIER    02 47 42 93 07 ext 33    emercier@med.univ-tours.fr   
CH Vesoul Withdrawn
Vesoul, France, 70000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Study Director: Jean-Pierre QUENOT Centre Hospitalier Universitaire Dijon
Principal Investigator: Saber Davide BARBAR CHU de Nimes
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01682590     History of Changes
Other Study ID Numbers: Quenot IDEAL-ICU 
Study First Received: September 10, 2012
Last Updated: January 26, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire Dijon:
septic shock; acute renal failure; renal remplacement therapy; mortality; intensive care; critical care; acute kidney injury

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Shock, Septic
Infection
Inflammation
Kidney Diseases
Pathologic Processes
Sepsis
Shock
Systemic Inflammatory Response Syndrome
Urologic Diseases

ClinicalTrials.gov processed this record on February 07, 2016