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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard RRT initiation
Accelerated 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, Acute kidney injury, Dialysis, Hemodialysis, Critical illness

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Admission to an intensive care unit (ICU)
  3. Evidence of kidney dysfunction [serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)]

  4. Evidence of severe AKI defined by at least 1 of the following 3 criteria:

    i) ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization; OR ii) Achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization; OR iii) Urine output < 6.0 mL/kg over the preceding 12 hours

Exclusion Criteria:

  1. Serum potassium > 5.5 mmol/L
  2. Serum bicarbonate < 15 mmol/L
  3. Presence of a drug overdose that necessitates initiation of RRT
  4. Lack of commitment to ongoing life support (including RRT)
  5. Any RRT within the previous 2 months (either acute or chronic RRT)
  6. Kidney transplant within the past 365 days
  7. Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 20 mL/min/1.73 m2
  8. Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis
  9. Clinician(s) caring for patient believe(s) that immediate RRT is mandated

  10. Clinician(s) caring for patient believe(s) that deferral of RRT initiation is mandated

    • at their discretion, clinicians may administer a bolus of intravenous furosemide (ie, "furosemide stress test") and evaluate the subsequent urine output to help guide decision making regarding the likelihood of AKI progression

Sites / Locations

  • University of Alabama at Birmingham
  • University of Florida
  • University of Kentucy
  • Mayo Clinic
  • Rhode Island Hospital
  • The Miriam Hospital
  • Ballarat Hospital
  • Flinder Medical Centre
  • Bendigo Hospital
  • Eastern Hospital (Box Hill and Maroondah Hospital)
  • Concord Hospital
  • The Northern Hospital
  • Geelong Hospital
  • Austin Hospital
  • Nepean Hospital
  • The Alfred Hospital
  • Nambour General Hospital
  • Western Health (Footscray Hospital & Sunshine Hospital)
  • St. Vincent's Hospital
  • Royal North Shore Hospital
  • Royal Prince Alfred Hospital
  • Princess Alexandra Hospital
  • Medical University Graz
  • Medical University Innsbruck
  • Vienna General Hospital
  • Antwerp University Hospital
  • Ghent University Hospital
  • Hospital de Clínicas de Porto Alegre - Rio Grande do Sul
  • Peter Lougheed Centre
  • Foothills Hospital
  • Misericordia Community Hospital
  • Mazankowski Alberta Heart Institute
  • University of Alberta Hospital
  • Grey Nuns Community Hospital
  • Royal Alexandra Hospital
  • Red Deer Regional Hospital
  • Sturgeon Community Hospital
  • Surrey Memorial Hospital, Fraser Health
  • St. Paul's Hospital - Providence Health Care
  • Royal Jubilee Hospital
  • Victoria General Hospital
  • Health Sciences Centre
  • Memorial University of Newfoundland
  • Hamilton General Hospital
  • Juravinski Hospital
  • St. Joseph's Healthcare Hamilton
  • Kingston General Hospital
  • London Health Sciences Centre, University Hospital
  • London Health Sciences Centre, Victoria Hospital
  • Trillium Health Partners - Credit Valley Hospital
  • Trillium Health Partners - Mississauga Hospital
  • Lakeridge Health
  • The Ottawa Hospital, Civic Campus
  • The Ottawa Hospital, General Campus
  • Health Sciences North
  • Mount Sinai Hospital
  • St. Michael's Hospital
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital
  • Toronto Western Hospital
  • Centre hospitalier de l'université de Montréal (Notre Dame)
  • Centre hospitalier de l'université de Montréal (St. Luc)
  • CHUM - Hôtel Dieu Montreal
  • Hopital Maisonneuve-Rosemont
  • McGill University Health Centre (MUHC)
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval (IUCPQ)
  • Centre Hospitalier Universitaire de Quebec (CHUQ)
  • Centre Hôspitalier universitaire de Sherbrooke (CHUS)
  • Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)
  • Regina Qu'Appelle Health Region
  • Beijing Friendship Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • The First Hospital of Jilin University
  • Xiangya Hospital Central South University
  • Guizhou Provincial People's Hospital
  • Shandong Provincial Hospital
  • Zhongda Hospital Southeast University
  • Renmin Hospital of Wuhan University
  • Zhongnan Hospital of Wuhan University
  • The First Affiliated Hospital of Xi'An Jiaotong University
  • The First Affiliated Hospital of Xiamen University
  • Henan Provincial People's Hospital
  • Helsinki University Central Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Hopital Louis Mourier
  • Klinikum Coburg
  • University Hospital Münster
  • St. Vincent's University Hospital
  • San Raffaele Hospital
  • Auckland City Hospital
  • Auckland Hospital DCCM
  • Christchurch Hospital
  • Hawke's Bay Hospital
  • Rotorua Hospital
  • Wellington Hospital
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Stoke Mandeville Hospital
  • Wycombe General Hospital
  • Leeds Teaching Hospital
  • Lewisham Hospital
  • King's College Hospital
  • Guy's and St. Thomas Hospital
  • Nottingham University Hospital
  • Princess Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard RRT initiation

Accelerated RRT initiation

Arm Description

RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.

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

Outcomes

Primary Outcome Measures

All-cause mortality.

Secondary Outcome Measures

RRT dependence
Composite of death or RRT dependence.
Measurement of estimated glomerular filtration rate.
Measurement of albuminuria.
Major adverse kidney outcomes.
Defined as death, RRT dependence or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR).
Mechanical ventilation-free days.
Vasoactive therapy-free days
ICU-free days
Hospitalization-free days
Death in ICU
EuroQoL EQ-5D-5L.
A measure of health-related quality of life and patient utility.
Health care costs.
Composite of death or RRT dependence.

Full Information

First Posted
September 29, 2015
Last Updated
January 20, 2020
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia, Baxter Healthcare Corporation, The George Institute, National Institute for Health Research, United Kingdom, Medical Research Institute of New Zealand, Health Research Council, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT02568722
Brief Title
Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
Official Title
STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia, Baxter Healthcare Corporation, The George Institute, National Institute for Health Research, United Kingdom, Medical Research Institute of New Zealand, Health Research Council, New Zealand

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 to standard initiation, leads to: Improved survival (primary outcome); and Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
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% with delays in RRT initiation implicated as a possible contributor. A recent meta-analysis suggested that earlier initiation of RRT may improve survival, but this is based on data derived overwhelmingly from observational studies. The investigators recently completed a multi-centre randomized controlled pilot trial that confirmed the feasibility of allocating patients to two different strategies of RRT initiation. Patient recruitment and follow-up, as well as patient safety, were successfully demonstrated during the pilot phase of this research program. The optimal timing of RRT initiation is an existing knowledge gap and a clear priority for investigation.

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, Acute kidney injury, Dialysis, Hemodialysis, Critical illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3019 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard RRT initiation
Arm Type
Active Comparator
Arm Description
RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
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 the patient meeting the eligibility criteria.
Intervention Type
Other
Intervention Name(s)
Standard RRT initiation
Intervention Description
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.
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.
Primary Outcome Measure Information:
Title
All-cause mortality.
Time Frame
90 days following study randomization.
Secondary Outcome Measure Information:
Title
RRT dependence
Time Frame
90 days following study randomization.
Title
Composite of death or RRT dependence.
Time Frame
90 days following study randomization.
Title
Measurement of estimated glomerular filtration rate.
Time Frame
90 days following study randomization.
Title
Measurement of albuminuria.
Time Frame
90 days following study randomization.
Title
Major adverse kidney outcomes.
Description
Defined as death, RRT dependence or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR).
Time Frame
90 days following study randomization.
Title
Mechanical ventilation-free days.
Time Frame
Measured from randomization through day 28.
Title
Vasoactive therapy-free days
Time Frame
Measured from randomization through day 28.
Title
ICU-free days
Time Frame
Measured from randomization through day 28.
Title
Hospitalization-free days
Time Frame
Measured from randomization through day 90.
Title
Death in ICU
Time Frame
Measured in-hospital and at day 28.
Title
EuroQoL EQ-5D-5L.
Description
A measure of health-related quality of life and patient utility.
Time Frame
Measured at day 90 and at day 365.
Title
Health care costs.
Time Frame
Measured from baseline through day 365.
Title
Composite of death or RRT dependence.
Time Frame
Measured at day 365.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Admission to an intensive care unit (ICU) Evidence of kidney dysfunction [serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)] Evidence of severe AKI defined by at least 1 of the following 3 criteria: i) ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization; OR ii) Achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization; OR iii) Urine output < 6.0 mL/kg over the preceding 12 hours Exclusion Criteria: Serum potassium > 5.5 mmol/L Serum bicarbonate < 15 mmol/L Presence of a drug overdose that necessitates initiation of RRT Lack of commitment to ongoing life support (including RRT) Any RRT within the previous 2 months (either acute or chronic RRT) Kidney transplant within the past 365 days Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 20 mL/min/1.73 m2 Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis Clinician(s) caring for patient believe(s) that immediate RRT is mandated Clinician(s) caring for patient believe(s) that deferral of RRT initiation is mandated at their discretion, clinicians may administer a bolus of intravenous furosemide (ie, "furosemide stress test") and evaluate the subsequent urine output to help guide decision making regarding the likelihood of AKI progression
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 Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of Kentucy
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Ballarat Hospital
City
Ballarat
ZIP/Postal Code
3350
Country
Australia
Facility Name
Flinder Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Bendigo Hospital
City
Bendigo
ZIP/Postal Code
3550
Country
Australia
Facility Name
Eastern Hospital (Box Hill and Maroondah Hospital)
City
Box Hill
Country
Australia
Facility Name
Concord Hospital
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
The Northern Hospital
City
Epping
ZIP/Postal Code
3076
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
ZIP/Postal Code
NSW 2747
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
Nambour General Hospital
City
Nambour
ZIP/Postal Code
QLD 4560
Country
Australia
Facility Name
Western Health (Footscray Hospital & Sunshine Hospital)
City
St Albans
ZIP/Postal Code
VIC 3021
Country
Australia
Facility Name
St. Vincent's Hospital
City
Sydney
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Vienna General Hospital
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium
Facility Name
Hospital de Clínicas de Porto Alegre - Rio Grande do Sul
City
Rio Branco
Country
Brazil
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Misericordia Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 4H5
Country
Canada
Facility Name
Mazankowski Alberta Heart Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Red Deer Regional Hospital
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 4E7
Country
Canada
Facility Name
Sturgeon Community Hospital
City
St. Albert
State/Province
Alberta
ZIP/Postal Code
T8N 6C4
Country
Canada
Facility Name
Surrey Memorial Hospital, Fraser Health
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
St. Paul's Hospital - Providence Health Care
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z 6R5
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3X9
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre, Victoria Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
Trillium Health Partners - Credit Valley Hospital
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Trillium Health Partners - Mississauga Hospital
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre hospitalier de l'université de Montréal (Notre Dame)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre hospitalier de l'université de Montréal (St. Luc)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHUM - Hôtel Dieu Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval (IUCPQ)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec (CHUQ)
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Centre Hôspitalier universitaire de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)
City
Trois-Rivières
State/Province
Quebec
Country
Canada
Facility Name
Regina Qu'Appelle Health Region
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Facility Name
Guizhou Provincial People's Hospital
City
Guiyang
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Facility Name
The First Affiliated Hospital of Xi'An Jiaotong University
City
Xi'an
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
Country
China
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Hopital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
University Hospital Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
San Raffaele Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1148
Country
New Zealand
Facility Name
Auckland Hospital DCCM
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Hawke's Bay Hospital
City
Hastings
Country
New Zealand
Facility Name
Rotorua Hospital
City
Rotorua
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Stoke Mandeville Hospital
City
Aylesbury
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Wycombe General Hospital
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Facility Name
Leeds Teaching Hospital
City
Leeds
Country
United Kingdom
Facility Name
Lewisham Hospital
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Guy's and St. Thomas Hospital
City
London
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Princess Royal University Hospital
City
Orpington
ZIP/Postal Code
BR6 8ND
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32668114
Citation
STARRT-AKI Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group; United Kingdom Critical Care Research Group; Canadian Nephrology Trials Network; Irish Critical Care Trials Group; Bagshaw SM, Wald R, Adhikari NKJ, Bellomo R, da Costa BR, Dreyfuss D, Du B, Gallagher MP, Gaudry S, Hoste EA, Lamontagne F, Joannidis M, Landoni G, Liu KD, McAuley DF, McGuinness SP, Neyra JA, Nichol AD, Ostermann M, Palevsky PM, Pettila V, Quenot JP, Qiu H, Rochwerg B, Schneider AG, Smith OM, Thome F, Thorpe KE, Vaara S, Weir M, Wang AY, Young P, Zarbock A. Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury. N Engl J Med. 2020 Jul 16;383(3):240-251. doi: 10.1056/NEJMoa2000741. Erratum In: N Engl J Med. 2020 Jul 15;:
Results Reference
derived
PubMed Identifier
31462203
Citation
STARRT-AKI Investigators. Statistical analysis plan for the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. Crit Care Resusc. 2019 Sep;21(3):162-170.
Results Reference
derived
PubMed Identifier
31218013
Citation
STARRT-AKI Investigators. STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Jun 10;6:2054358119852937. doi: 10.1177/2054358119852937. eCollection 2019.
Results Reference
derived

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

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