I.D.E.A.L.-I.C.U. (Initiation of Dialysis EArly Versus Late in Intensive Care Unit)
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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. |
- 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.
- 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 |
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:
- Patients with chronic renal failure classified beyond the "injury" stage according to the RIFLE classification at dialysis.
- 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)
- Patients aged less than 18 years
- Pregnant women.
- Moribund patients whose life expectancy is less than 24 hours
- 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…)
- Patients with advance directives indicating their wish not to be resuscitated.
- Patients under legal guardianship.
Contacts and Locations| Contact: Jean-Pierre QUENOT | 3 80 29 36 85 ext 33 | jean-pierre.quenot@chu-dijon.fr |
| 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 | |
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