search
Back to results

Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury (STARRT-AKI)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Accelerated RRT initiation
Standard RRT initiation
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring renal replacement therapy, dialysis, acute kidney injury, hemodialysis, critical illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (all of these need to be present):

  1. Age ≥ 18 years
  2. Admission to an intensive care unit

  3. Evidence of kidney dysfunction (serum creatinine ≥ 100 µmol/L (women) or

    ≥ 130 µmol/L (men))

  4. 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

  5. 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
  6. Central venous pressure ≥ 8 mmHg

Exclusion Criteria (the presence of one of these would disqualify eligibility):

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

Sites / Locations

  • University of Alberta Hospital
  • St. Joseph's Healthcare
  • London Health Sciences Centre - Victoria Hospital
  • London Health Sciences Centre - University Hospital
  • The Ottawa Hospital, General Campus
  • The Ottawa Hospital, Civic Campus
  • St. Michael's Hospital
  • University Health Network
  • Mount Sinai Hospital
  • Sunnybrook Health Sciences Centre
  • Centre hopitalier universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard RRT initiation

Accelerated RRT initiation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feasibility of enrollment
>50% of eligible patients are successfully enrolled in the trial
Feasibility of 90-day follow-up
Vital status and need for RRT at 90 days are successfully captured in >95% of participants
Safety outcomes
Serious adverse effects, with a particular focus on those that are potentially attributable to the study treatment, vascular accesss complications (including hemorrhage, thrombosis and infection) and complications associated with the delivery of RRT (dialysis-associated hypotension, electrolyte abnormalities) will be examined.

Full Information

First Posted
March 13, 2012
Last Updated
September 11, 2014
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), Alere San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT01557361
Brief Title
Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury
Acronym
STARRT-AKI
Official Title
STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), Alere San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and Safe, from the perspective of potential adverse events associated with earlier initiation of RRT
Detailed Description
Acute kidney injury (AKI) is a common and devastating complication of critical illness. Once AKI is established, treatment is largely supportive and no intervention has been found to restore kidney function or improve overall survival. Renal replacement therapy (RRT), usually in the form of hemodialysis, is frequently needed to manage patients with severe AKI. Such patients have an in-hospital mortality that consistently exceeds 50%. Delay in the initiation of RRT has been implicated as a possible contributor to this poor outcome. A recent meta-analysis suggested that earlier initiation of RRT may improve survival. However, completed trials to date have been small, single centre, limited by study quality, and have shown considerable heterogeneity in terms of definitions used for "early" RRT initiation. 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: Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and Safe, from the perspective of potential adverse events associated with the earlier or later initiation of RRT This pilot trial is intended to guide and inform the design of a phase III multicentre randomized trial of accelerated versus standard initiation of RRT in critically ill patients that will evaluate the impact of the intervention on 90-day all-cause mortality and recovery of kidney function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
renal replacement therapy, dialysis, acute kidney injury, hemodialysis, critical illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard RRT initiation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Accelerated RRT initiation
Arm Type
Experimental
Arm Description
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility.
Intervention Type
Other
Intervention Name(s)
Accelerated RRT initiation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard RRT initiation
Intervention Description
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: Serum potassium ≥6.0 mmol/L, or Serum bicarbonate ≤ 10 mmol/L, or Evidence of severe respiratory failure, based on a PaO2/FiO2 <200 and bilateral infiltrates on the chest x-ray, or By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization
Primary Outcome Measure Information:
Title
Feasibility of protocol adherence
Description
>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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Feasibility of enrollment
Description
>50% of eligible patients are successfully enrolled in the trial
Time Frame
14 days
Title
Feasibility of 90-day follow-up
Description
Vital status and need for RRT at 90 days are successfully captured in >95% of participants
Time Frame
90 days
Title
Safety outcomes
Description
Serious adverse effects, with a particular focus on those that are potentially attributable to the study treatment, vascular accesss complications (including hemorrhage, thrombosis and infection) and complications associated with the delivery of RRT (dialysis-associated hypotension, electrolyte abnormalities) will be examined.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (all of these need to be present): 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 Exclusion Criteria (the presence of one of these would disqualify eligibility): 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Wald, MDCM MPH
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean M Bagshaw, MD MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 6B5
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
The Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre hopitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24093950
Citation
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.
Results Reference
derived

Learn more about this trial

Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury

We'll reach out to this number within 24 hrs