Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (akiki)
Résumé
BACKGROUND: There is currently no validated strategy for the timing of renal replacement therapy (RRT) for acute kidney injury (AKI) in the intensive care unit (ICU) when short-term life-threatening metabolic abnormalities are absent. No adequately powered prospective randomized study has addressed this issue to date. As a result, significant practice heterogeneity exists and may expose patients to either unnecessary hazardous procedures or undue delay in RRT.
METHODS: This is a multicenter, prospective, randomized, open-label parallel-group clinical trial that compares the effect of two RRT initiation strategies on overall survival of critically ill patients receiving intravenous catecholamines or invasive mechanical ventilation and presenting with AKI classification stage 3 (KDIGO 2012). In the 'early' strategy, RRT is initiated immediately. In the 'delayed' strategy, clinical and metabolic conditions are closely monitored and RRT is initiated only when one or more events (severity criteria) occur, including: oliguria or anuria 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 persisting despite medical treatment, arterial blood pH <7.15 in a context of pure metabolic acidosis (PaCO2 < 35 mmHg) or in a context of mixed acidosis with a PaCO2 ≥ 50 mmHg without possibility of increasing alveolar ventilation, acute pulmonary edema due to fluid overload despite diuretic therapy leading to severe hypoxemia requiring oxygen flow rate >5 l/min to maintain SpO2 > 95% or FiO2 > 50% under invasive or noninvasive mechanical ventilation. The primary outcome measure is overall survival, measured from randomization (D0) until death, regardless of the cause. The minimum follow-up duration for each patient will be 60 days. Two interim analyses are planned, blinded to group allocation. It is expected that there will be 620 subjects in all.
CONCLUSIONS: The AKIKI study will be one of the very few large randomized controlled trials evaluating mortality according to the timing of RRT in critically ill patients with AKI classification stage 3 (KDIGO 2012). Results should help clinicians decide when to initiate RRT.
BACKGROUND: ClinicalTrials.gov NCT01932190.
Mots clés
Mesh:Acute Kidney Injury/therapy*
Mesh:Acute Kidney Injury/physiopathology
Mesh:Acute Kidney Injury/mortality
Mesh:Patient Selection
Mesh:Intensive Care Units*
Mesh:Injury Severity Score
Mesh:Risk Assessment
Mesh:Risk Factors
Mesh:Time Factors
Mesh:Time-to-Treatment*
Mesh:Treatment Outcome
Mesh:Humans
Mesh:France
Mesh:Research Design
Mesh:Renal Replacement Therapy/mortality
Mesh:Renal Replacement Therapy/methods*
Mesh:Renal Replacement Therapy/adverse effects
Mesh:Prospective Studies
Mesh:Predictive Value of Tests
Renal replacement therapy
Acute kidney injury
Treatment outcome
Critical care
Mesh:Decision Support Techniques
Mesh:Acute Kidney Injury/diagnosis
Mesh:Critical Illness
Mesh:Acute Kidney Injury/blood
Mesh:Clinical Protocols
Mesh:Biomarkers/blood
Domaines
Sciences du Vivant [q-bio]| Origine | Fichiers éditeurs autorisés sur une archive ouverte |
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