Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Marlies Ostermann
ORCID ID
Contact details
Guy's & St Thomas Hospital
Department of Critical Care
Westminster Bridge Road
London
SE1 9RT
United Kingdom
+44 (0)2071883038
Marlies.Ostermann@gstt.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
NCT02568722
Protocol/serial number
1.2
Study information
Scientific title
STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): a multi-centre, randomized, controlled trial
Acronym
STARRT-AKI
Study hypothesis
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
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:
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Mortality measured at 90 days
Secondary outcome measures
Recovery of kidney function defined as independence from dialysis at 90 days
Overall trial start date
01/02/2018
Overall trial end date
31/05/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
580
Participant 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
Recruitment start date
01/02/2018
Recruitment end date
31/05/2020
Locations
Countries of recruitment
Canada, United Kingdom
Trial participating centre
Guy's & St Thomas Hospital
Westminster Bridge Road
London
SE1 9RT
United Kingdom
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
31/05/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list