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

Primary Purpose

Septic Shock, Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification)

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Renal Remplacement Therapy
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Septic Shock focused on measuring septic shock; acute renal failure; renal remplacement therapy; mortality; intensive care; critical care; acute kidney injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CH Avignon
  • CH Belfort
  • CHU Besançon
  • CH de BOURG-EN-BRESSE
  • CHU Caen
  • CHU Clermont-Ferrand
  • CH Dieppe
  • CHU Dijon
  • CH Sud Essonne - Site Etampes
  • Hôpital Raymond-Poincaré GARCHES (AP-HP)
  • CHU Grenoble
  • CH de LA ROCHE sur YON
  • Groupe Hospitalier de l'institut Catholique de LILLE
  • CHU de Lyon
  • CHU Montpellier
  • CHU Lapeyronie
  • CHG Mulhouse
  • CHU Nancy Brabois
  • CHU Nîmes
  • CHR d'Orléans
  • Hôpital Cochin
  • HOPITAL BICHAT Claude-Bernard
  • CHU Lyon Sud
  • CH Périgueux
  • CHU de Strasbourg - Nouvel hôpital civil
  • CHR Metz
  • CHRU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early initiation of RRT

Deferred RRT

Arm Description

Start of RRT within a maximum of 12 hours after randomisation.

Start of RRT between 48 and 60 hours after randomisation.

Outcomes

Primary Outcome Measures

Progression free survival
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
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.

Full Information

First Posted
September 10, 2012
Last Updated
November 26, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01682590
Brief Title
I.D.E.A.L.-I.C.U. (Initiation of Dialysis EArly Versus deLayed in Intensive Care Unit)
Acronym
IDEAL-ICU
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification)
Keywords
septic shock; acute renal failure; renal remplacement therapy; mortality; intensive care; critical care; acute kidney injury

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early initiation of RRT
Arm Type
Experimental
Arm Description
Start of RRT within a maximum of 12 hours after randomisation.
Arm Title
Deferred RRT
Arm Type
Active Comparator
Arm Description
Start of RRT between 48 and 60 hours after randomisation.
Intervention Type
Procedure
Intervention Name(s)
Renal Remplacement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free survival
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Comparison of the tolerance and evaluation quality of life
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Patients with chronic renal at dialysis. 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) Patients already had hemodialysis before their arrival in the intensive care unit 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. Patients participing in another interventional study that may influence the prognosis of patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre QUENOT
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Saber Davide BARBAR
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
CH Belfort
City
Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CH de BOURG-EN-BRESSE
City
Bourg-en-Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14003
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
CH Dieppe
City
Dieppe
ZIP/Postal Code
76200
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CH Sud Essonne - Site Etampes
City
Etampes
ZIP/Postal Code
91 150
Country
France
Facility Name
Hôpital Raymond-Poincaré GARCHES (AP-HP)
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CH de LA ROCHE sur YON
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Groupe Hospitalier de l'institut Catholique de LILLE
City
Lille
ZIP/Postal Code
59160
Country
France
Facility Name
CHU de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHG Mulhouse
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
CHU Nancy Brabois
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
CHU Nîmes
City
Nîmes
ZIP/Postal Code
30000
Country
France
Facility Name
CHR d'Orléans
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HOPITAL BICHAT Claude-Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CH Périgueux
City
Périgueux
ZIP/Postal Code
24019
Country
France
Facility Name
CHU de Strasbourg - Nouvel hôpital civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHR Metz
City
Thionville
ZIP/Postal Code
57100
Country
France
Facility Name
CHRU Tours
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24998258
Citation
Barbar SD, Binquet C, Monchi M, Bruyere R, Quenot JP. 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. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.
Results Reference
background
PubMed Identifier
30304656
Citation
Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.
Results Reference
derived

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

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