Critical IllnessRADAR-2NCT03512392
Role of Active Deresuscitation After Resuscitation-2
A study testing Conservative fluid and deresuscitation strategy in people with Critical Illness and Sepsis, run by Belfast Health and Social Care Trust at 8 sites in United Kingdom.
Trial summary
RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Trauma
- What is being tested?
- Conservative fluid and deresuscitation strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 10 Apr 2018to 17 Jul 2021
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation
- Treating ICU doctor expects patient to require treatment in an ICU beyond the next calendar day
- Between 24 and 48 hours from ICU admission at the time of randomisation
Who cannot join
- Age < 16 years
- Body weight <40kg (measured or estimated)
- Diabetic ketoacidosis or Hyperosmolar hyperglycaemic state
- Non-traumatic subarachnoid haemorrhage
- Acute cardiac failure or cardiogenic shock
- End-stage renal failure (on dialysis)
Show all 14Show fewer
- Known to be pregnant
- Suspected or proven active diabetes insipidus (DDAVP within 24 hours)
- Not expected to survive for 72 hours
- Active 'Do not attempt resuscitation' order
- Refusal of consent
- Inability of personal consultee to understand written or verbal information and for whom no interpreter is available
- Known allergy to one or more of the study drugs
- Inability to measure fluid balance
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Northern Health and Social Care Trust
Antrim, Northern Ireland
Belfast City Hospital
Belfast, Northern Ireland, BT12 6AB
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
South-Eastern Health and Social Care Trust
Dundonald, Northern Ireland
Western Health and Social Care Trust
Londonderry
Manchester University NHS Foundation Trust
Manchester
Aneurin Bevan University Health Board
Newport, Gwent
Sunderland Royal Hospital
Sunderland, Tyne and Wear
About this study
Official title: Role of Active Deresuscitation After Resuscitation- 2: a Pilot Randomised Controlled Trial of Conservative Fluid Management Versus Usual Care in Critical Illness
RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.
Read the detailed description
The optimal approach to fluid balance in critically ill patients is uncertain. A recent systematic review found low quality evidence in favour of a conservative fluid or deresuscitative approach (active removal of accumulated fluid using diuretics and/or renal replacement therapy) compared with a liberal strategy or usual care. The RADAR-2 pilot randomised trial will compare conservative fluid and deresuscitation with usual care in patients who are mechanically ventilated in an intensive care unit. The main hypothesis is that in critically ill patients, a post-resuscitation fluid strategy comprising conservative fluid administration and active deresuscitation reduces net fluid balance, is safe and improves clinical outcomes.
- Conditions
- Critical Illness, Sepsis, Trauma
- Being tested
- Conservative fluid and deresuscitation strategy, Usual care strategy
- Keywords
- fluid therapy, furosemide, diuretics, Injections, Intravenous, Infusions, Intravenous, Spironolactone, Indapamide
- Medical subject headings
- Critical Illness, Sepsis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative fluid and deresuscitation strategyOther
Conservative administration of intravenous fluid and active deresuscitation using diuretics or renal replacement therapy for eligible patients
Usual care strategyOther
Usual care at the discretion of the clinical team
| Study group | Role | What they receive |
|---|---|---|
| Conservative fluid and deresuscitation | Experimental | * Fluid restriction (avoidance of maintenance intravenous fluid and minimisation of drug diluent volumes)
* Daily assessment of eligibility for deresuscitation for 3 days (eligible if oedema in more than 1 site and cumulative fluid balance > 2 litres)
* Deresuscitation to target negative daily fluid balance of 1 to 3 litres:
5mg Indapamide daily (enteral) 100mg Spironolactone daily (enteral) 0.5mg/kg furosemide once (intravenous, max 40mg) 2.5-20mg/hr furosemide infusion titrated to effect OR continuous renal replacement therapy with fluid removal Receives: Other: Conservative fluid and deresuscitation strategy |
| Usual care | Active comparator | Usual care at the discretion of the treating team Receives: Other: Usual care strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 3 fluid balance
Change in fluid balance (mL) between the beginning of study day 2 and the beginning of study day 3.
Measured: From beginning of day 2 to the beginning of study day 3.
Secondary outcomes (10)
Cumulative fluid balance
Cumulative fluid balance (mL) from ICU admission
Measured: Up to the beginning of days 3 and 5, and at ICU discharge (estimated median day 7)
Incidence of significant protocol violations
Incidence of significant protocol violations (total number of patients, per site, and by nature of protocol violation) up to day 5 (intervention period)
Measured: Up to study day 5
Incidence of reported adverse events
Incidence of reported adverse events up to day 5 (intervention period)
Measured: Up to study day 5
Change in Sequential Organ Function Assessment scores
Change in Sequential Organ Function Assessment scores from baseline, overall (0-24) and 6 individual organ sub scores (respiratory, cardiovascular, neurological, coagulation, renal and liver, each scored 0-4 which are added to give a total score). Higher values represent more deranged physiology and predict mortality for critically ill patients.
Measured: From baseline until day 3 and day 5
Mortality
Mortality
Measured: 28 and 180 days
Duration of mechanical ventilation
Duration of mechanical ventilation in survivors and non-survivors (number of days or part thereof from initiation of mechanical ventilatory support until unassisted breathing)
Measured: 28 days
Length of ICU stay
Length of ICU stay (number of days or part thereof from admission to an ICU or being under the care of a critical care team or consultant until ICU discharge)
Measured: 28 days
Acute kidney injury
Incidence of new acute kidney injury defined as estimated KDIGO Stage 3 (before and after correction for fluid balance)
Measured: Up to day 5.
Cognitive function
Cognitive function score (assessed using the Montreal Cognitive Assessment (MoCA-blind) instrument)
Measured: 180 days
Health-related quality of life
Health-related quality of life (HR-QoL) (assessed using absolute values of a telephone-administered EQ-5D (EuroQoL 5 Dimension Scale) questionnaire). This has 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, each of which are scored 1-5, with 1 being best and 5 being worst health. Each domain is reported separately. A total score is generated and is indexed to population reference values for that country (in this case UK) according to the time of data collection. It is therefore not possible to pre-specify a range for the indexed score.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start10 Apr 2018
- Primary completion21 Jan 2020
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, open-label, allocation concealed, pilot trial
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Jon Silversides, MB BCh, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512392
- Sponsor's protocol ID
- 17057JS-AS
- Acronym
- RADAR-2
- Status last verified
- Apr 2022
- First submitted
- 5 Dec 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silversides JA, Major E, Ferguson AJ, Mann EE, McAuley DF, Marshall JC, Blackwood B, Fan E. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. doi: 10.1007/s00134-016-4573-3. Epub 2016 Oct 12.
PubMed 27734109Silversides JA, McMullan R, Emerson LM, Bradbury I, Bannard-Smith J, Szakmany T, Trinder J, Rostron AJ, Johnston P, Ferguson AJ, Boyle AJ, Blackwood B, Marshall JC, McAuley DF. Feasibility of conservative fluid administration and deresuscitation compared with usual care in critical illness: the Role of Active Deresuscitation After Resuscitation-2 (RADAR-2) randomised clinical trial. Intensive Care Med. 2022 Feb;48(2):190-200. doi: 10.1007/s00134-021-06596-8. Epub 2021 Dec 16.
PubMed 34913089
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Active Deresuscitation After Resuscitation- 2: a Pilot Randomised Controlled Trial of Conservative Fluid Management Versus Usual Care in Critical Illness
- ClinicalTrials.gov ID
- NCT03512392
- Acronym / sponsor ID
- RADAR-2 / 17057JS-AS
- Conditions
- Critical Illness, Sepsis, Trauma
- Keywords
- fluid therapy, furosemide, diuretics, Injections, Intravenous, Infusions, Intravenous, Spironolactone, Indapamide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, University of Toronto
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 30 Apr 2018 (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.
RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.
Detailed description
The optimal approach to fluid balance in critically ill patients is uncertain. A recent systematic review found low quality evidence in favour of a conservative fluid or deresuscitative approach (active removal of accumulated fluid using diuretics and/or renal replacement therapy) compared with a liberal strategy or usual care. The RADAR-2 pilot randomised trial will compare conservative fluid and deresuscitation with usual care in patients who are mechanically ventilated in an intensive care unit. The main hypothesis is that in critically ill patients, a post-resuscitation fluid strategy comprising conservative fluid administration and active deresuscitation reduces net fluid balance, is safe and improves clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open-label, allocation concealed, pilot trial
| Arm | Type | Receives |
|---|---|---|
| Conservative fluid and deresuscitation | Experimental | Other: Conservative fluid and deresuscitation strategy* Fluid restriction (avoidance of maintenance intravenous fluid and minimisation of drug diluent volumes) * Daily assessment of eligibility for deresuscitation for 3 days (eligible if oedema in more than 1 site and cumulative fluid balance > 2 litres) * Deresuscitation to target negative daily fluid balance of 1 to 3 litres: 5mg Indapamide daily (enteral) 100mg Spironolactone daily (enteral) 0.5mg/kg furosemide once (intravenous, max 40mg) 2.5-20mg/hr furosemide infusion titrated to effect OR continuous renal replacement therapy with fluid removal |
| Usual care | Active comparator | Other: Usual care strategyUsual care at the discretion of the treating team |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Invasive mechanical ventilation
- Treating ICU doctor expects patient to require treatment in an ICU beyond the next calendar day
- Between 24 and 48 hours from ICU admission at the time of randomisation
Key exclusion criteria (14 listed)
- Age < 16 years
- Body weight <40kg (measured or estimated)
- Diabetic ketoacidosis or Hyperosmolar hyperglycaemic state
- Non-traumatic subarachnoid haemorrhage
- Acute cardiac failure or cardiogenic shock
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 |
|---|---|---|
| Conservative fluid and deresuscitation strategyConservative administration of intravenous fluid and active deresuscitation using diuretics or renal replacement therapy for eligible patients | Other | Conservative fluid and deresuscitation |
| Usual care strategyUsual care at the discretion of the clinical team | Other | Usual care |
Primary outcome
Day 3 fluid balance
Time frame: From beginning of day 2 to the beginning of study day 3.
Change in fluid balance (mL) between the beginning of study day 2 and the beginning of study day 3.
10 secondary outcomes
Cumulative fluid balance
Time frame: Up to the beginning of days 3 and 5, and at ICU discharge (estimated median day 7)
Incidence of significant protocol violations
Time frame: Up to study day 5
Incidence of reported adverse events
Time frame: Up to study day 5
Change in Sequential Organ Function Assessment scores
Time frame: From baseline until day 3 and day 5
Mortality
Time frame: 28 and 180 days
Duration of mechanical ventilation
Time frame: 28 days
Length of ICU stay
Time frame: 28 days
Acute kidney injury
Time frame: Up to day 5.
Cognitive function
Time frame: 180 days
Health-related quality of life
Time frame: 180 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 21 Apr 2022.
- Background: PubMed 27734109Silversides JA, Major E, Ferguson AJ, Mann EE, McAuley DF, Marshall JC, Blackwood B, Fan E. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. doi: 10.1007/s00134-016-4573-3. Epub 2016 Oct 12.
- Results publication: PubMed 34913089Silversides JA, McMullan R, Emerson LM, Bradbury I, Bannard-Smith J, Szakmany T, Trinder J, Rostron AJ, Johnston P, Ferguson AJ, Boyle AJ, Blackwood B, Marshall JC, McAuley DF. Feasibility of conservative fluid administration and deresuscitation compared with usual care in critical illness: the Role of Active Deresuscitation After Resuscitation-2 (RADAR-2) randomised clinical trial. Intensive Care Med. 2022 Feb;48(2):190-200. doi: 10.1007/s00134-021-06596-8. Epub 2021 Dec 16.
- Individual participant dataSharing planned: No
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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.
Jon Silversides, MB BCh principal investigator
Belfast Health and Social Care Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative fluid and deresuscitation strategy in people with Critical Illness and Sepsis, run by Belfast Health and Social Care Trust at 8 sites in United Kingdom.
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 3 inclusion and 14 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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.
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?
Day 3 fluid balance (time frame: From beginning of day 2 to the beginning of study day 3.). 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 NCT03512392, which also lists 2 linked publications.
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 21 Apr 2022.