Condition category
Urological and Genital Diseases
Date applied
03/02/2019
Date assigned
18/02/2019
Last edited
22/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Nil known

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

Sponsor information

Organisation

University of Toronto

Sponsor details

Applied Health Research Centre
30 Bond Street
Toronto
M5B 1W8
Canada

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes

22/02/2019: Internal review.