Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury

NCT01557361 | Completed Phase 2 DMC

• 1 other identifier: CIHR MOP 111116
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

Brief 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 with standard initiation, is:

1. 1.Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
2. 2.Safe, from the perspective of potential adverse events associated with earlier initiation of RRT

Conditions

Acute Kidney Injury

Keywords

renal replacement therapy; dialysis; acute kidney injury; hemodialysis; critical illness

Outcome Measures

Primary Outcomes (1)

• Feasibility of protocol adherence

  \>90% of participants in the accelerated initiation arm start RRT within 12 hours of eligibility AND \>90% of participants randomized to the standard initiation arm who ultimately receive RRT, start RRT at least 12 hours following eligibility determination

  14 days

Secondary Outcomes (3)

• Feasibility of enrollment

  14 days

• Feasibility of 90-day follow-up

  90 days

• Safety outcomes

  14 days

Study Arms (2)

Standard RRT initiation

ACTIVE COMPARATOR

RRT is initiated \>12 hours after eligibility determination. Once a decision is made to start RRT, a dialysis catheter will be placed and RRT initiated as soon as possible.

Other: Standard RRT initiation

Accelerated RRT initiation

EXPERIMENTAL

A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility.

Other: Accelerated RRT initiation

Interventions

Accelerated RRT initiation OTHER

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.

Accelerated RRT initiation

Standard RRT initiation OTHER

Patients will be carefully followed over a period of 7 days to identify potential indications for RRT. The trial team will ask that the clinical team consider RRT initiation if there are: I. Criteria for persistent AKI (serum creatinine has not declined by more than 50% from value recorded at time of eligibility) AND II. At least one of the following indications for RRT initiation: 1. Serum potassium ≥6.0 mmol/L, or 2. Serum bicarbonate ≤ 10 mmol/L, or 3. Evidence of severe respiratory failure, based on a PaO2/FiO2 \<200 and bilateral infiltrates on the chest x-ray, or 4. By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization

Standard RRT initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Admission to an intensive care unit
• Evidence of kidney dysfunction (serum creatinine ≥ 100 µmol/L (women) or
• ≥ 130 µmol/L (men))
• Evidence of severe AKI defined by at least 2 of the following 3 criteria:
• i-A 2-fold increase in serum creatinine during hospitalization or from a known pre-hospitalization baseline ii-Oliguria as defined by total urine output \< 6 mL/kg over the preceding 12 hours iii-Whole blood Neutrophil Gelatinase-Associated Lipocalin (NGAL) ≥ 400ng/mL
• Likelihood that an absolute indication for RRT will not arise in the subsequent 24 hours based on the most recent bloodwork for the following parameters: i- Serum potassium ≤ 5.5 mmol/L and ii- Serum bicarbonate ≥ 15 mmol/L
• Central venous pressure ≥ 8 mmHg

You may not qualify if:

• Lack of commitment to ongoing life support
• Presence of a drug overdose that necessitates initiation of RRT
• Any RRT within the previous 2 months
• Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
• Advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 30 mL/min/1.73 m2, based on pre-hospitalization blood work
• Kidney transplant within the past 365 days
• At the time of screening, doubling of serum creatinine has been present for \> 48 hours
• Clinician(s) caring for patient believe(s) that immediate dialysis is absolutely mandated
• Clinician(s) caring for patient believe(s) that deferral of dialysis initiation is mandated
• Patient or substitute decision maker can not provide consent within 12 hours of study eligibility

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alere San Diego: collaborator

Study Sites (11)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6C 6B5, Canada

Location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Centre hopitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (3)

• Wing S, Neto AS, Bellomo R, Clark EG, Gallagher M, Liangos O, Prasad B, Silver SA, Tolwani A, Bagshaw S, Wald R. CKD Progression after Acute Kidney Injury: A Secondary Analysis of the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury Trial. Kidney360. 2025 Apr 1;6(4):636-644. doi: 10.34067/KID.0000000663. Epub 2024 Dec 3.

  PMID: 39625781 DERIVED

• Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

  PMID: 36416787 DERIVED

• Smith OM, Wald R, Adhikari NK, Pope K, Weir MA, Bagshaw SM; Canadian Critical Care Trials Group. Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial. Trials. 2013 Oct 5;14:320. doi: 10.1186/1745-6215-14-320.

  PMID: 24093950 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ron Wald, MDCM MPH

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Sean M Bagshaw, MD MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 19, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2013-08

Locations

CA (11)