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

Septic Shock Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01682590
• Other study ID #: Quenot IDEAL-ICU
• Status: Terminated
• Phase: Phase 3
• Start date: July 2012

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure (as Defined by the Failure Stage of the RIFLE Classification)
• Renal Insufficiency
• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
France	CH Avignon	Avignon
France	CH Belfort	Belfort
France	CHU Besançon	Besançon
France	CH de BOURG-EN-BRESSE	Bourg-en-Bresse
France	CHU Caen	Caen
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CH Dieppe	Dieppe
France	CHU Dijon	Dijon
France	CH Sud Essonne - Site Etampes	Etampes
France	Hôpital Raymond-Poincaré GARCHES (AP-HP)	Garches
France	CHU Grenoble	Grenoble
France	CH de LA ROCHE sur YON	La Roche sur Yon
France	Groupe Hospitalier de l'institut Catholique de LILLE	Lille
France	CHU de Lyon	Lyon
France	CHU Lapeyronie	Montpellier
France	CHU Montpellier	Montpellier
France	CHG Mulhouse	Mulhouse
France	CHU Nancy Brabois	Nancy
France	CHU Nîmes	Nîmes
France	CHR d'Orléans	Orleans
France	HOPITAL BICHAT Claude-Bernard	Paris
France	Hôpital Cochin	Paris
France	CH Périgueux	Périgueux
France	CHU Lyon Sud	Pierre-Bénite
France	CHU de Strasbourg - Nouvel hôpital civil	Strasbourg
France	CHR Metz	Thionville
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

References & Publications (1)

Barbar SD, Binquet C, Monchi M, Bruyère 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	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.	90 days