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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02568722




Registration number
NCT02568722
Ethics application status
Date submitted
29/09/2015
Date registered
6/10/2015
Date last updated
22/01/2020

Titles & IDs
Public title
Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
Scientific title
STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
Secondary ID [1] 0 0
STARRT-AKI: Principal Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standard RRT initiation
Other interventions - Accelerated RRT initiation

Active Comparator: Standard RRT initiation - 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.

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


Other interventions: 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 interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality.
Timepoint [1] 0 0
90 days following study randomization.
Secondary outcome [1] 0 0
RRT dependence
Timepoint [1] 0 0
90 days following study randomization.
Secondary outcome [2] 0 0
Composite of death or RRT dependence.
Timepoint [2] 0 0
90 days following study randomization.
Secondary outcome [3] 0 0
Measurement of estimated glomerular filtration rate.
Timepoint [3] 0 0
90 days following study randomization.
Secondary outcome [4] 0 0
Measurement of albuminuria.
Timepoint [4] 0 0
90 days following study randomization.
Secondary outcome [5] 0 0
Major adverse kidney outcomes. - Defined as death, RRT dependence or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR).
Timepoint [5] 0 0
90 days following study randomization.
Secondary outcome [6] 0 0
Mechanical ventilation-free days.
Timepoint [6] 0 0
Measured from randomization through day 28.
Secondary outcome [7] 0 0
Vasoactive therapy-free days
Timepoint [7] 0 0
Measured from randomization through day 28.
Secondary outcome [8] 0 0
ICU-free days
Timepoint [8] 0 0
Measured from randomization through day 28.
Secondary outcome [9] 0 0
Hospitalization-free days
Timepoint [9] 0 0
Measured from randomization through day 90.
Secondary outcome [10] 0 0
Death in ICU
Timepoint [10] 0 0
Measured in-hospital and at day 28.
Secondary outcome [11] 0 0
EuroQoL EQ-5D-5L. - A measure of health-related quality of life and patient utility.
Timepoint [11] 0 0
Measured at day 90 and at day 365.
Secondary outcome [12] 0 0
Health care costs.
Timepoint [12] 0 0
Measured from baseline through day 365.
Secondary outcome [13] 0 0
Composite of death or RRT dependence.
Timepoint [13] 0 0
Measured at day 365.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ballarat Hospital - Ballarat
Recruitment hospital [2] 0 0
Flinder Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [4] 0 0
Eastern Hospital (Box Hill and Maroondah Hospital) - Box Hill
Recruitment hospital [5] 0 0
Concord Hospital - Concord
Recruitment hospital [6] 0 0
The Northern Hospital - Epping
Recruitment hospital [7] 0 0
Geelong Hospital - Geelong
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [12] 0 0
Western Health (Footscray Hospital & Sunshine Hospital) - St Albans
Recruitment hospital [13] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [14] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [15] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [16] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3550 - Bendigo
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
2139 - Concord
Recruitment postcode(s) [6] 0 0
3076 - Epping
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
NSW 2747 - Kingswood
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment postcode(s) [11] 0 0
QLD 4560 - Nambour
Recruitment postcode(s) [12] 0 0
VIC 3021 - St Albans
Recruitment postcode(s) [13] 0 0
2010 - Sydney
Recruitment postcode(s) [14] 0 0
2065 - Sydney
Recruitment postcode(s) [15] 0 0
- Sydney
Recruitment postcode(s) [16] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama