The Artificial Kidney Initiation in Kidney Injury 2

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 Injury (AKIKI) was the first large prospective multicenter randomized trial published on this topic. This study (published in the New England Journal of Medicine, July 2017) showed no significant difference between an early and delayed RRT initiation strategy in term of mortality. Nearly 50% of patients escaped RRT in the delayed strategy and this strategy was associated with less catheter-related infections and faster renal function recovery. Two (serum urea concentration \>40 mmol/l and oliguria/anuria for more than 72 hours) of the 5 criteria which mandated RRT in the delayed strategy are still open to debate since they have never been shown to put patient at danger. To go further into our investigation of RRT criteria, the investigators designed a study that would compare the "delayed strategy" used in AKIKI that can now be considered as "standard" with another in which RRT is delayed for a longer period in the absence of a life-threatening complication (such as hyperkalemia or severe overload pulmonary edema).

Conditions

• Renal Replacement Therapy for Acute Kidney Injury in ICU

Interventions

PROCEDURE

Standard strategy

RRT is initiated within 12 hours after documentation of serum urea concentration \>40 mmol/l and/or an oliguria/anuria for more than 72 hours. The timing of its initiation will be recorded and RRT will continue until criteria for cessation are observed. This arm corresponds to the "delayed strategy" in the published AKIKI trial (NEJM 2016),

PROCEDURE

Delayed strategy

RRT will be initiated only if one or more of above-mentioned potentially severe situations occur (identical to those used during the observational study) or if serum urea concentration reaches 50 mmol/L (this level being chosen in order to avoid extreme elevations of serum urea levels as mentioned above). The physician in charge will be allowed to try a medical treatment. Patients will not receive RRT whatever the duration of anuria/oliguria if any above-mentioned indication for RRT is not present. When required, RRT will be performed with the same modalities and stopped according to the same criteria as in the "no further delayed" RRT strategy, with special care to avoid dialysis disequilibrium syndrome (see below). The decision to initiate RRT in the "delayed strategy" arm of the trial will have to be approved by the attending physician(s) involved in patient's care in order to make sure that it corresponds to her/his usual practice.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Didier DREYFUSS, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-07

Primary Completion

2019-10-11

Completion

2020-03-15

Countries

• France
• Guadeloupe

Study Locations