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

This study is currently recruiting participants.
Verified January 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: January 8, 2013
Last verified: January 2013
  Purpose

Acute renal failure is one of the most feared complications of severe sepsis or septic shock and occurs in respectively 23% and 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 "injury" 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 severe sepsis or septic shock who develop acute renal failure.

Secondary objectives include: to compare the impact of the two hemodialysis strategies on 28 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 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
Severe Sepsis
Septic Shock
Acute Renal Failure (as Defined by the "Injury" 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 Injury Stage Versus Deferred Dialysis in Intensive Care Unit Patiens With Severe Sepsis or 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 "injury" 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 severe sepsis or 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 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 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: 710
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 severe sepsis or septic shock who develop acute renal failure (as defined by the "injury" stage of the RIFLE classification) will be eligible for inclusion.

Severe sepsis is defined as the presence of suspected or documented infection, systemic inflammatory response syndrome (SIRS) and at least one sign of hypoperfusion or organ dysfunction:

  • Neurological (encephalopathy with Glasgow score <13),
  • Respiratory (PaO2/FiO2 <300 mmHg)
  • Hematological (platelet count < 100,000/mm3)
  • Hepatic (bilirubinemia >2mg/dL)
  • Metabolic acidosis (lactates >2.5 mMol/L or base deficit >5 mEq/L or HCO3─< 18mEq/L)
  • Circulatory (systolic arterial blood pressure <90 mmHg or drop of at least 40 mmHg in normal blood pressure in the absence of any other cause of hypotension)

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.

Septic shock is defined as severe sepsis with persistent hypotension despite adequate vascular filling and/or need for intropic or vaso-active drugs.

Acute renal insufficiency is defined as the "injury" stage of the RIFLE classification, i.e. the presence of at least one of the following criteria:

  • Increased creatinine x 2 times the baseline value
  • Decrease of >50% in glomerular filtration rate (GFR)
  • Oliguria < 0.5 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 failure classified beyond the "injury" stage according to the RIFLE classification at dialysis.
  2. 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 aged less than 18 years
  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
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

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            
CH Colmar Recruiting
Colmar, France, 68000
Contact: Henry LESSIRE     3 89 12 43 63 ext 33     henry.lessire@ch-colmar.fr    
Principal Investigator: Henry LESSIRE            
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            
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            
Le Kremlin-Bicetre (Aphp) Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Jean Louis TEBOUL     1 45 21 35 47 ext 33     jean-louis.teboul@bct.aphp.fr    
Principal Investigator: Jean-Louis TEBOUL            
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-Paris (APHP) Recruiting
Paris, France, 75014
Contact: Benoit MISSET     1 44 12 34 15 ext 33     bmisset@hpsj.fr    
Principal Investigator: Benoit MISSET            
Hôpital Saint-Louis- Paris (APHP) Recruiting
Paris, France, 75010
Contact: Elie AZOULAY     1 42 49 94 21 ext 33     elie.azoulay@sls.aphp.fr    
Principal Investigator: Elie AZOULAY            
CHU Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Julien BOHE         julien.bohe@chu-lyon.fr    
Principal Investigator: Julien BOHE            
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Olivier MIMOZ     5 49 44 46 00 ext 33     o.mimoz@chu-poitiers.fr    
Principal Investigator: Olivier MIMOZ            
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: René ROBERT     5 49 44 40 07 ext 33     rene.robert@chu-poitiers.fr    
Principal Investigator: René ROBERT            
CHU Reims Recruiting
Reims, France, 51100
Contact: Joël COUSSON     3 26 78 30 22 ext 33     jcousson@chu-reims.fr    
Principal Investigator: Joël COUSSON            
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

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 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013