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Trials. 2015 Apr 17;16:170. doi: 10.1186/s13063-015-0718-x.

Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (AKIKI).

Author information

  • 1Assistance Publique-Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France. stephanegaudry@gmail.com.
  • 2Université Paris Diderot, Sorbonne Paris Cité, ECEVE, UMRS 1123, F-75010, Paris, France. stephanegaudry@gmail.com.
  • 3INSERM, ECEVE, U1123, F-75010, Paris, France. stephanegaudry@gmail.com.
  • 4INSERM, CIC-EC 1425, UMR 1123, Paris, France. david.hajage@lmr.aphp.fr.
  • 5Assistance Publique-Hôpitaux de Paris, Hôpital Louis Mourier, Département d'Epidémiologie et Recherche Clinique, Paris, France. david.hajage@lmr.aphp.fr.
  • 6Université Paris Diderot, UMR 1123, Sorbonne Paris Cité, Paris, France. david.hajage@lmr.aphp.fr.
  • 7Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Henri Mondor, DHU A-TVB, Service de Réanimation Médicale, Créteil, France. frederique.schortgen@hmn.aphp.fr.
  • 8Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France. laurent.martin-lefevre@chd-vendee.fr.
  • 9INSERM, CIC-EC 1425, UMR 1123, Paris, France. florence.tubach@bch.aphp.fr.
  • 10Université Paris Diderot, UMR 1123, Sorbonne Paris Cité, Paris, France. florence.tubach@bch.aphp.fr.
  • 11Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Département d'Epidémiologie et Recherche Clinique, Paris, France. florence.tubach@bch.aphp.fr.
  • 12Service de Réanimation, CHU de Pointe à Pitre - Abymes, CHU de la Guadeloupe, Basse-Terre, France. bertrand.pons@chu-guadeloupe.fr.
  • 13Réanimation polyvalente, CH René Dubos, 95301, Pontoise, France. eric.boulet@ch-pontoise.fr.
  • 14CHU Bordeaux, Hôpital Pellegrin, 33000, Bordeaux, France. alexandre.boyer@chu-bordeaux.fr.
  • 15Département de réanimation médicale et médecine hyperbare, CHU Angers, Université d'Angers, Angers, France. nilerolle@chu-angers.fr.
  • 16Intensive Care Unit, Centre Hospitalier Sud Francilien, Corbeil Essonnes, France. guillaume.chevrel@ch-sud-francilien.fr.
  • 17Réanimation médicale, CHU Rouen, 76000, Rouen, France. dorothee.carpentier@chu-rouen.fr.
  • 18Medical Intensive Care Unit, Gabriel Montpied Teaching Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. alautrette@chu-clermontferrand.fr.
  • 19Medical-Surgical Intensive Care Unit, Hôpital de La Source, Centre Hospitalier Régional d'Orléans, BP 6709, , 45067, Orleans Cedex, France. anne.bretagnol@chr-orleans.fr.
  • 20Service de Pneumologie et Réanimation médicale, APHP, Groupe Hospitalier Pitié-Salpêtrière, Paris, France. julien.mayaux@psl.aphp.fr.
  • 21Réanimation polyvalente, CH Victor Dupouy, 95107, Argenteil Cedex, France. marina.thirion@ch-argenteuil.fr.
  • 22Réanimation, CH Cholet, 49300, Cholet, France. philippe.markowicz@ch-cholet.fr.
  • 23Service de Réanimation Détresses respiratoires aiguës et infections sévères, Hôpital Nord, Marseille, 13015, France. guillemette.thomas@ap-hm.fr.
  • 24Medical Intensive Care Unit, Archet I University Hospital, 151 Route Saint Antoine de Ginestière, 06200, Nice, France. dellamonica.j@chu-nice.fr.
  • 25Réanimation, CH de Beauvais, 60000, Beauvais, France. j.richecoeur@ch-beauvais.fr.
  • 26Medical Intensive Care Unit, Saint-Etienne University Hospital, Avenue Albert Raymond, Saint-Priest en Jarez, France. michael.darmon@chu-st-etienne.fr.
  • 27Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Henri Mondor, DHU A-TVB, Service de Réanimation Médicale, Créteil, France. nicolas.de-prost@hmn.aphp.fr.
  • 28CARMAS research group, UPEC-Université Paris-Est Créteil Val de Marne, Créteil, France. nicolas.de-prost@hmn.aphp.fr.
  • 29Réanimation médicale, Hôpital de la Croix Rousse, 69000, Lyon, France. hodane.yonis@chu-lyon.fr.
  • 30Réanimation Médicale et Toxicologique, Hôpital Lariboisière, INSERM U1144, Université Paris Diderot, Paris, France. bruno.megarbane@lrb.aphp.fr.
  • 31Réanimation, CH Poissy Saint Germain en laye, 78300, Poissy, France. yloubiere@chi-poissy-st-germain.fr.
  • 32Service de Pneumologie et Réanimation, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris and Université Pierre et Marie Curie, 4 Rue de la Chine, 75020, Paris, France. clarisseblayau@gmail.com.
  • 33Medical intensive care unit, University medical center and INSERM U-1088, University of Picardie, Amiens, France. maizel.julien@chu-amiens.fr.
  • 34Réanimation médico-chirurgicale, CH Versailles, 78000, Versailles, France. bzuber@ch-versailles.fr.
  • 35Centre de Réanimation, Hôpital R. Salengro, CHRU de Lill, Rue E. Laine, 59037, Lille Cedex, France. saadalla.nseir@chru-lille.fr.
  • 36AP-HP, Hôpital Saint Antoine, Service de Réanimation Médicale, Paris, F-75012, France. naike.bige@sat.aphp.fr.
  • 37INSERM, CIC-EC 1425, UMR 1123, Paris, France. isabelle.hoffmann@bch.aphp.fr.
  • 38Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Département d'Epidémiologie et Recherche Clinique, Paris, France. isabelle.hoffmann@bch.aphp.fr.
  • 39Assistance Publique-Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France. jean-damien.ricard@lmr.aphp.fr.
  • 40Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France. jean-damien.ricard@lmr.aphp.fr.
  • 41INSERM, IAME, U1137, F-75018, Paris, France. jean-damien.ricard@lmr.aphp.fr.
  • 42Assistance Publique-Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France. didier.dreyfuss@lmr.aphp.fr.
  • 43Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France. didier.dreyfuss@lmr.aphp.fr.
  • 44INSERM, IAME, U1137, F-75018, Paris, France. didier.dreyfuss@lmr.aphp.fr.
  • 45Present address: Intensive care unit, Hôpital Louis Mourier, 178 rue des Renouillers, 92110, Colombes, France. didier.dreyfuss@lmr.aphp.fr.

Abstract

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/DESIGN:

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.

DISCUSSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01932190.

PMID:
25902813
PMCID:
PMC4407416
DOI:
10.1186/s13063-015-0718-x
[PubMed - indexed for MEDLINE]
Free PMC Article
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