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Trial record 1 of 42 for:    ideal icu
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I.D.E.A.L.-I.C.U. (Initiation of Dialysis EArly Versus deLayed in Intensive Care Unit) (IDEAL-ICU)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682590
First Posted: September 11, 2012
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  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
Intervention Model: Parallel Assignment
Intervention Model Description:
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
Masking: None (Open Label)
Primary Purpose: Other
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 ]
    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 ]
    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.


Enrollment: 500
Study Start Date: July 2012
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682590


Locations
France
CH Avignon
Avignon, France, 84000
CH Belfort
Belfort, France, 90000
CHU Besançon
Besançon, France, 25000
CH de BOURG-EN-BRESSE
Bourg-en-Bresse, France, 01012
CHU Caen
Caen, France, 14003
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63100
CH Dieppe
Dieppe, France, 76200
CHU Dijon
Dijon, France, 21000
CH Sud Essonne - Site Etampes
Etampes, France, 91 150
Hôpital Raymond-Poincaré GARCHES (AP-HP)
Garches, France, 92380
CHU Grenoble
Grenoble, France, 38043
CH de LA ROCHE sur YON
La Roche sur Yon, France, 85000
Groupe Hospitalier de l'institut Catholique de LILLE
Lille, France, 59160
CHU de Lyon
Lyon, France, 69000
CHU Montpellier
Montpellier, France, 34000
CHU Lapeyronie
Montpellier, France, 34295
CHG Mulhouse
Mulhouse, France, 68100
CHU Nancy Brabois
Nancy, France, 54000
CHU Nîmes
Nîmes, France, 30000
CHR d'Orléans
Orleans, France, 45100
Hôpital Cochin
Paris, France, 75014
HOPITAL BICHAT Claude-Bernard
Paris, France, 75018
CHU Lyon Sud
Pierre-Bénite, France, 69495
CH Périgueux
Périgueux, France, 24019
CHU de Strasbourg - Nouvel hôpital civil
Strasbourg, France, 67000
CHR Metz
Thionville, France, 57100
CHRU Tours
Tours, France
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
First Submitted: September 10, 2012
First Posted: September 11, 2012
Last Update Posted: February 2, 2017
Last Verified: January 2016

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