Status:
COMPLETED
The Artificial Kidney Initiation in Kidney Injury 2
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Renal Replacement Therapy for Acute Kidney Injury in ICU
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The timing of renal replacement therapy (RRT) in the context of severe acute kidney injury (AKI) is one the most debated issues in critical care medicine. The Artificial Kidney Initiation in Kidney In...
Detailed Description
The timing of renal replacement therapy (RRT) in the context of severe acute kidney injury (AKI) is one the most debated issues in critical care medicine. The Artificial Kidney Initiation in Kidney In...
Eligibility Criteria
Inclusion
- All of the following criteria must be fulfilled to be included in the observational study (first stage):
- Adults (\>18 years)
- Hospitalized in a study ICU.
- Evidence of acute kidney injury compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression and who receive (or received for the same episode) invasive mechanical ventilation and/or catecholamine infusion.
- Acute kidney injury stage 3 of KDIGO classification defined by at least one of the following criteria: serum creatinine concentration of more than 4 mg/dl (354 µmol/liter) or greater than 3 times the baseline creatinine level, anuria (urine output of 100 ml/day or less) for more than 12 hours, oliguria (urine output below 0.3 ml/kg/h or below 500 ml/day) for more than 24 hours.
- To be randomized (randomization stage), supplemental criteria must be fulfilled. These criteria can appear either immediately after inclusion in the observational stage, or during the follow-up of the patient in the observational stage, in the absence of any non-inclusion criteria (listed below) at the time of randomization:
- Oliguria/anuria (urine output \<0.3 ml/kg/h or \<500 ml/day) for more than 72 hours or serum urea concentration comprised between 40 and 50 mmol/l.
- Affiliation to a social security regime
Exclusion
- Severity criteria mandating immediate RRT initiation (Table 1)
- Serum urea level \> 50 mmol/l
- Severe chronic renal failure (defined by a creatinine clearance \< 30 ml/min)
- Patients with inclusion criteria already present for more than 24 hours (to avoid delayed inclusions)
- AKI caused by urinary tract obstruction or renal vessel obstruction or tumour lysis syndrome or thrombotic microangiopathy or acute glomerulopathy
- Poisoning by a dialyzable agent
- Child C liver cirrhosis
- Cardiac arrest without awakening
- Moribund state (patient likely to die within 24h)
- Patient having already received RRT for the current episode of AKI
- Renal transplant
- Treatment limitation (withholding or withdrawal)
- Previous inclusion in this study
- Subject deprived of freedom, subject under a legal protective measure
- Pregnant or breastfeeding woman
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
768 Patients enrolled
Trial Details
Trial ID
NCT03396757
Start Date
May 7 2018
End Date
March 15 2020
Last Update
June 16 2021
Active Locations (41)
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1
CH Alès
Alès, France
2
CHU Amiens
Amiens, France
3
CH Avignon
Avignon, France
4
Groupe Hospitalier Carnelle-Portes de l'Oise Site Beaumont / Oise
Beaumont-sur-Oise, France