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Clinical trial

Artificial Kidney Initiation in Kidney Injury (AKIKI)

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Last updated:23rd Jun 2016
Identifier: NCT01932190
Artificial Kidney Initiation in Kidney Injury (AKIKI)

The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:

1. an "early" strategy where RRT is started immediately when a RIFLE F status is documented

2. a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.

The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.

Study Type: Interventional (Clinical Trial)
Actual Enrollment: 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
Study Start Date: September 2013
Actual Primary Completion Date: February 2016
Actual Study Completion Date: February 2016

- Experimental: Early RRT strategy
- Experimental: Delayed RRT strategy

Category Value
Study type(s) Interventional
Expected enrolment 620
Study start date 1 September 2013
Estimated primary completion date 1 February 2016

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