The effect of starting dialysis earlier than usual in patients with damaged kidneys
| ISRCTN | ISRCTN13470139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13470139 |
| IRAS number | 191390 |
| ClinicalTrials.gov number | NCT02568722 |
| Secondary identifying numbers | IRAS 191390 |
- Submission date
- 03/02/2019
- Registration date
- 18/02/2019
- Last edited
- 07/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
More than 1 in 2 critically ill patients in the intensive care unit (ICU) develop acute kidney injury (AKI). A proportion of patients need dialysis treatment, also known as replacement therapy (RRT). The aim of RRT is to remove toxins and excess fluid which may have accumulated because of kidney failure. At present it is not clear whether it is best to start RRT only when patients have evidence of severe AKI or whether it is better to initiate RRT earlier, i.e. as soon as patients have signs of impaired kidney function.
Who can participate?
Patients aged over 18 years admitted to the intensive care unit with serious kidney problems.
What does the study involve?
RRT consists of having a catheter (a tube or ‘line’) in a vein in the neck or in the groin through which blood flows to a dialysis machine where it is cleansed and excess water is removed. The cleansed blood is then returned to the patient via the catheter.
What are the possible benefits and risks of participating?
RRT can be lifesaving but has side effects, possibly including bleeding and bloodstream infections. Importantly, if at any stage the treating clinician feels that RRT is mandatory or alternatively should not be started, their judgement will override. Also, there will be no change in any clinical management and no extra blood samples will be taken.
Where is the study run from?
Guy's & St Thomas Hospital, Westminster Bridge Road, London, SE1 9RT, UK.
When is the study starting and how long is it expected to run for?
February 2018 to March 2020.
Who is funding the study?
The National Institute for Health Research (United Kingdom) Health Technology Assessment programme.
Who is the main contact?
Mrs. Marlies Ostermann, Marlies.Ostermann@gstt.nhs.uk
Contact information
Scientific
Guy's & St Thomas Hospital
Department of Critical Care
Westminster Bridge Road
London
SE1 9RT
United Kingdom
| Phone | +44 (0)2071883038 |
|---|---|
| Marlies.Ostermann@gstt.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): a multi-centre, randomized, controlled trial |
| Study acronym | STARRT-AKI |
| Study objectives | In critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to a conservative strategy consistent with standard care, leads to: 1. improved survival at 90 days; and 2. better recovery of kidney function, defined as independence from dialysis at 90 days. |
| Ethics approval(s) | Approved 22/05/2017, Camberwell St Giles REC (Institute of Psychiatry, Seminar Room 6, IOP Main Building, SE5 8AF, +44 (0) 207 1048044, NRESCommittee.London-CamberwellStGiles@nhs.net), ref: |
| Health condition(s) or problem(s) studied | Acute kidney injury |
| Intervention | Patients in the ICU with early AKI will be randomised to RRT using standard criteria versus accelerated (earlier) RRT. Patients randomised to the accelerated arm will be started on RRT within 12 hours of eligibility. In patients randomised to standard initiation, RRT will be discouraged until serum potassium >5.9 mmol/L, pH <7.21 or serum bicarbonate <13 mmol/L, respiratory failure due to fluid overload, or persistent AKI stage 2 or 3 for >72 hours. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Mortality measured at 90 days |
| Secondary outcome measures | Recovery of kidney function defined as independence from dialysis at 90 days |
| Overall study start date | 01/02/2018 |
| Completion date | 31/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 580 |
| Total final enrolment | 2927 |
| 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 in women and ≥ 130 µmol/L in men] 4. Evidence of severe AKI |
| Key exclusion criteria | 1. Lack of commitment to provide RRT as part of limitation of ongoing life support. 2. Presence of a drug overdose that necessitates initiation of RRT. 3. Any RRT within the previous 2 months. 4. Kidney transplant within the past 365 days. 5. Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate <20 mL/min/1.73 m2 in a patient who is not on chronic dialysis. 6. Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy (eg, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, malignant hypertension, scleroderma renal crisis) or acute interstitial nephritis. 7. Likelihood that an absolute indication for RRT will arise in the subsequent 24 hours based on the most recent blood work for the following parameters: serum K >5.5 8. Likelihood that an absolute indication for RRT will arise in the subsequent 24 hours based on the most recent blood work for the following parameters: serum bicarbonate <15 mmol/L |
| Date of first enrolment | 01/02/2018 |
| Date of final enrolment | 31/05/2020 |
Locations
Countries of recruitment
- Canada
- England
- United Kingdom
Study participating centre
London
SE1 9RT
United Kingdom
Sponsor information
Research organisation
Applied Health Research Centre
30 Bond Street
Toronto
M5B 1W8
Canada
"ROR" |
https://ror.org/03dbr7087 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/07/2020 | 18/11/2022 | Yes | No | |
| Protocol file | version 3.3 | 15/12/2020 | 07/08/2023 | No | No |
Additional files
Editorial Notes
07/08/2023: The following changes have been made:
1. Protocol file uploaded.
2. The IRAS number has been added from the protocol.
18/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
23/05/2019: ClinicalTrials.gov number added.
22/02/2019: Internal review.
