Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

Summary

The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:

1. Improved survival (primary outcome); and
2. Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

Conditions

• Acute Kidney Injury

Interventions

OTHER

Standard RRT initiation

In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops: serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.

OTHER

Accelerated RRT initiation

A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• The George Institute

  collaborator OTHER

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Medical Research Institute of New Zealand

  collaborator OTHER

• Health Research Council, New Zealand

  collaborator OTHER

• Unity Health Toronto

  lead OTHER

Principal Investigators

• Ron Wald, MDCM MPH · Unity Health Toronto

• Sean M Bagshaw, MD MSc · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• United States
• Australia
• Austria
• Belgium
• Brazil
• Canada
• China
• Finland
• France
• Germany
• Ireland
• Italy
• New Zealand
• Switzerland
• United Kingdom

Study Locations