Acute Kidney InjuryPhase 2REVERSE-AKINCT03251131
REVERSE-AKI Randomized Controlled Pilot Trial
A Phase 2 study testing Restrictive fluid management in people with Acute Kidney Injury and Critical Illness, run by Helsinki University Central Hospital at 7 sites in 5 countries.
Trial summary
Observational studies among patients with acute kidney injury (AKI) have shown an association with fluid accumulation and increased mortality. Trials among other subgroups of critically ill patients have demonstrated that restricting fluid input after the initial resuscitation appears safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Critical Illness
- What is being tested?
- Restrictive fluid management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 8 Nov 2017to 30 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-years or older and admitted to critical care with an arterial line in place
- The patient has been in critical care for at least 12 hours but no more than 72 hours
- The patient has AKI but is not receiving acute RRT:
- For the purpose of the study AKI is defined the by the following criteria:
- Increase in serum creatinine over 1.5-times above baseline without a decline of 27umol/l or more from the last preceding measurement (at least 12 hours apart) AND/OR
- Overall urine output less than 0.5ml/kg/h (or 6ml/kg) for the previous 12h (with urine catheter in place for the period)
- The patient is judged by the treating clinician not to be intravascularly hypovolemic
- The patient is likely to remain in critical care for 48 hours after randomization
Who cannot join
- Active bleeding necessitating transfusion
- Maintenance fluid therapy is necessary due to diabetic ketoacidosis, non-ketotic coma, severe burns or other clinical reason determined by the medical staff
- Need for RRT due to intoxication of a dialyzable toxin
- Commencement of RRT is expected in the next 6 hours
- On chronic renal replacement therapy (maintenance dialysis or renal transplant)
- Presence or a strong clinical suspicion of parenchymal AKI (for example glomerulonephritis, vasculitis, acute interstitial nephritis), or post-renal obstruction
Show all 13Show fewer
- Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L)
- Need for extracorporeal membrane oxygenation or molecular absorbent recirculating system (MARS-therapy)
- Pregnant or lactating
- Patients who are not to receive full active treatment
- No baseline creatinine available
- Lack of consent
- The patient has been enrolled in another trial where co-enrollment is not feasible
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Australia2 sites
Canberra Hospital
Canberra
Austin Hospital
Melbourne, Victoria, 3048
United Kingdom2 sites
Guy's and St Thomas Hospital
London
Royal London Hospital, Barts Health NHS Trust
London
About this study
Official title: REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial
Observational studies among patients with acute kidney injury (AKI) have shown an association with fluid accumulation and increased mortality. Trials among other subgroups of critically ill patients have demonstrated that restricting fluid input after the initial resuscitation appears safe.
The objective if this study is to determine whether a fluid restrictive treatment regimen will lead to a lower cumulative fluid balance at 72 hours from randomization in critically ill patients with AKI and whether this approach is safe and feasible.
Read the detailed description
Acute kidney injury (AKI) is common in the critically ill and associates with adverse outcomes. Patients with AKI are frequently have low urine output and are at high risk of developing fluid overload. Fluid overload has been associated with an increased risk for mortality in such patients. Previous trials in critically ill patients found that a 'restrictive fluid therapy' after resuscitation was safe. Implementing a restrictive fluid therapy approach in patients with AKI may also be of benefit. To date, however, no randomized trial has been performed to evaluate the safety and feasibility of implementing a 'restrictive fluid therapy' approach compared to standard fluid therapy in patients with AKI.
In this pilot randomized controlled trial we will evaluate the implementation of a fluid restrictive approach, compared to standard therapy, in adult critically ill patients with acute kidney injury.
- Conditions
- Acute Kidney Injury, Critical Illness
- Being tested
- Restrictive fluid management
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive fluid managementOther
Daily fluid input is restricted to drugs and nutrition. Fluid boluses and blood products can be given if clinically indicated. Matching fluid output to fluid input whenever possible using diuretics if needed, and additionally, if clinically necessary and plausible, commencing renal replacement therapy. If renal replacement therapy is not deemed clinically desirable, acceptance of a less than targeted fluid balance.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive fluid management | Experimental | Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance. Receives: Other: Restrictive fluid management |
| Standard therapy | No intervention | Randomized allocation of standard care at the clinician's discretion in accordance with current best practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative fluid balance
Measured: 72 hours
Secondary outcomes (5)
Duration of acute kidney injury
Defined according to Kidney Disease: Improving Global Outcomes criteria
Measured: ICU discharge/14 days
Number of patients requiring renal replacement therapy
Measured: 14 days
Cumulative fluid balance
Measured: 24 hours
Cumulative fluid balance
Measured: ICU discharge/ 7 days
Cumulative dose of diuretics
Measured: ICU discharge/ 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start8 Nov 2017
- Primary completion31 Jan 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Guy's and St Thomas' NHS Foundation Trust, University Hospital, Ghent, Medical University Innsbruck, University of Lausanne Hospitals
- Responsible party
- Principal investigator, Suvi Vaara, Helsinki University Central Hospital
- Investigators
- Suvi Vaara, MD, PhD, Principal investigator, Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, FinlandMarlies Ostermann, MD, PhD, Principal investigator, Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251131
- Sponsor's protocol ID
- HUS/1782/2017
- Acronym
- REVERSE-AKI
- Status last verified
- Dec 2020
- First submitted
- 12 Aug 2017
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vaara ST, Ostermann M, Selander T, Bitker L, Schneider A, Poli E, Hoste E, Joannidis M, Zarbock A, van Haren F, Prowle J, Pettila V, Bellomo R. Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):831-838. doi: 10.1111/aas.13557. Epub 2020 Feb 26.
PubMed 32022904
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03251131
- Acronym / sponsor ID
- REVERSE-AKI / HUS/1782/2017
- Conditions
- Acute Kidney Injury, Critical Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Guy's and St Thomas' NHS Foundation Trust, University Hospital, Ghent, Medical University Innsbruck, University of Lausanne Hospitals
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational studies among patients with acute kidney injury (AKI) have shown an association with fluid accumulation and increased mortality. Trials among other subgroups of critically ill patients have demonstrated that restricting fluid input after the initial resuscitation appears safe.
The objective if this study is to determine whether a fluid restrictive treatment regimen will lead to a lower cumulative fluid balance at 72 hours from randomization in critically ill patients with AKI and whether this approach is safe and feasible.
Detailed description
Acute kidney injury (AKI) is common in the critically ill and associates with adverse outcomes. Patients with AKI are frequently have low urine output and are at high risk of developing fluid overload. Fluid overload has been associated with an increased risk for mortality in such patients. Previous trials in critically ill patients found that a 'restrictive fluid therapy' after resuscitation was safe. Implementing a restrictive fluid therapy approach in patients with AKI may also be of benefit. To date, however, no randomized trial has been performed to evaluate the safety and feasibility of implementing a 'restrictive fluid therapy' approach compared to standard fluid therapy in patients with AKI.
In this pilot randomized controlled trial we will evaluate the implementation of a fluid restrictive approach, compared to standard therapy, in adult critically ill patients with acute kidney injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive fluid management | Experimental | Other: Restrictive fluid managementRestrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance. |
| Standard therapy | No intervention | –Randomized allocation of standard care at the clinician's discretion in accordance with current best practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-years or older and admitted to critical care with an arterial line in place
- The patient has been in critical care for at least 12 hours but no more than 72 hours
- The patient has AKI but is not receiving acute RRT:
- The patient is judged by the treating clinician not to be intravascularly hypovolemic
- The patient is likely to remain in critical care for 48 hours after randomization
Key exclusion criteria (13 listed)
- Active bleeding necessitating transfusion
- Maintenance fluid therapy is necessary due to diabetic ketoacidosis, non-ketotic coma, severe burns or other clinical reason determined by the medical staff
- Need for RRT due to intoxication of a dialyzable toxin
- Commencement of RRT is expected in the next 6 hours
- On chronic renal replacement therapy (maintenance dialysis or renal transplant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive fluid managementDaily fluid input is restricted to drugs and nutrition. Fluid boluses and blood products can be given if clinically indicated. Matching fluid output to fluid input whenever possible using diuretics if needed, and additionally, if clinically necessary and plausible, commencing renal replacement therapy. If renal replacement therapy is not deemed clinically desirable, acceptance of a less than targeted fluid balance. | Other | Restrictive fluid management |
Primary outcome
Cumulative fluid balance
Time frame: 72 hours
5 secondary outcomes
Duration of acute kidney injury
Time frame: ICU discharge/14 days
Number of patients requiring renal replacement therapy
Time frame: 14 days
Cumulative fluid balance
Time frame: 24 hours
Cumulative fluid balance
Time frame: ICU discharge/ 7 days
Cumulative dose of diuretics
Time frame: ICU discharge/ 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 32022904Vaara ST, Ostermann M, Selander T, Bitker L, Schneider A, Poli E, Hoste E, Joannidis M, Zarbock A, van Haren F, Prowle J, Pettila V, Bellomo R. Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):831-838. doi: 10.1111/aas.13557. Epub 2020 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suvi Vaara, MD, PhD principal investigator
Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Marlies Ostermann, MD, PhD principal investigator
Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Restrictive fluid management in people with Acute Kidney Injury and Critical Illness, run by Helsinki University Central Hospital at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United Kingdom, Belgium, Finland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fluid balance (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.