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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 6, 2013
Last verified: June 2013
  Purpose

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 hemodialysis. Retrospective and observational studies have suggested that early initiation of hemodialysis could help to improve prognosis in these patients. Therefore, we aim to investigate wether early initiation of hemodialysis (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 hemodialysis (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 hemodialysis strategies on 28, 180 et 360 day mortality, duration of mechanical ventilation, duration of hemodialysis, 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 dialysis at hospital discharge.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Early Initiation of Dialysis at the Failure Stage Versus Deferred Dialysis in Intensive Care Unit Patients in Premature Phase of the Septic Shock Who Develop Acute Renal Insufficiency. Randomized, Controlled Superiority Trial. IDEAL-ICU (Initiation od Dialysis Early vs Late in Intensive Care Unit) Study Group.

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 hemodialysis (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 hemodialysis (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 hemodialysis strategies on 28, 180 and 360 day mortality, duration of mechanical ventilation, duration of hemodialysis, 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 dialysis at hospital discharge.


Estimated Enrollment: 824
Study Start Date: July 2012
Arms Assigned Interventions
Experimental: Early initiation of dialysis
Start of hemodialysis within a maximum of 12 hours after diagnosis of acute renal failure.
Procedure: hemodialysis
Active Comparator: Deferred hemodialysis
Start of hemodialysis between 48 and 60 hours after diagnosis of acute renal failure.
Procedure: hemodialysis

  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/or need for intropic or 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

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.
  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 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 Chalon-Sur-Saône Recruiting
Chalon-Sur-Saône, France, 71100
Contact: Jean-Marc DOISE         
Principal Investigator: Jean-Marc DOISE         
CH Dieppe Not yet 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 Recruiting
Dijon, France, 21000
Contact: Nadine MILESI    3 80 29 53 78 ext 33    nadine.milesi@chu-dijon.fr   
Principal Investigator: Nadine MILESI         
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         
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 Recruiting
Melun, France, 77000
Contact: Mehran MONCHI    1 64 71 60 10 ext 33    m.monchi@free.fr   
Principal Investigator: Mehran MONCHI         
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         
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         
Hôpital Saint Joseph (APHP) Recruiting
Paris, France, 75014
Contact: Benoît MISSET    1 44 12 34 15 ext 33    bmisset@hpsj.fr   
Principal Investigator: Benoît MISSET         
CHU Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Julien BOHE       julien.bohe@chu-lyon.fr   
Principal Investigator: Julien BOHE         
CHU Reims Recruiting
Reims, France, 51100
Contact: Joël COUSSON    3 26 78 30 22 ext 33    jcousson@chu-reims.fr   
Principal Investigator: Joël COUSSON         
CHU de Strasbourg - Nouvel hôpital civil Recruiting
Strasbourg, France, 67000
Contact: Ferhat MEZIANI         
Principal Investigator: Ferhat MEZIANI         
Hôpital de Hautepierre - CHU Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Vincent CASTELAIN    3 88 12 79 13 ext 33    vincent.castelain@chru-strasbourg.fr   
Principal Investigator: Vincent CASTELAIN         
CHR Metz Recruiting
Thionville, France, 57100
Contact: Guillaume LOUIS    6 47 93 74 69 ext 33    gus_louis@yahoo.fr   
Principal Investigator: Guillaume LOUIS         
CH Vesoul Recruiting
Vesoul, France, 70000
Contact: Sarah VALETTE    3 84 96 67 82 ext 33    s.valette@chi70.fr   
Principal Investigator: Sarah VALETTE         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided by Centre Hospitalier Universitaire Dijon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire Dijon:
septic shock; acute renal failure; hemodialysis; mortality.

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

ClinicalTrials.gov processed this record on November 19, 2014