A Phase 3 interventional study of Renal Remplacement Therapy in Septic Shock and Acute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification), sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 27 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Centre Hospitalier Universitaire Dijon · Phase 3, Interventional, and Other
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.
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 500 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.
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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 :
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:
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:
Start of RRT within a maximum of 12 hours after randomisation.
Procedure: Renal Remplacement Therapy
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.
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.
Time frame: 90 days
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.
Time frame: 90 days
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Dijon