Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Queen's University, Belfast | OTHER |
| University of Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative fluid and deresuscitation | Experimental |
|
|
| Usual care | Active Comparator | Usual care at the discretion of the treating team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative fluid and deresuscitation strategy | Other | Conservative administration of intravenous fluid and active deresuscitation using diuretics or renal replacement therapy for eligible patients |
| Measure | Description | Time Frame |
|---|---|---|
| Day 3 fluid balance | Change in fluid balance (mL) between the beginning of study day 2 and the beginning of study day 3. | From beginning of day 2 to the beginning of study day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative fluid balance | Cumulative fluid balance (mL) from ICU admission | Up to the beginning of days 3 and 5, and at ICU discharge (estimated median day 7) |
| Incidence of significant protocol violations |
| Measure | Description | Time Frame |
|---|---|---|
| Mean regional cerebral oxygen saturation | Near infra-red spectroscopic measurement of regional cerebral oxygen saturation), mean rScO2 level (%) | 72 hours from randomisation |
| Minimum regional cerebral oxygen saturation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jon Silversides, MB BCh | Belfast Health and Social Care Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aneurin Bevan University Health Board | Newport | Gwent | United Kingdom | |||
| Northern Health and Social Care Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27734109 | Background | 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. | |
| 34913089 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2020 | Jun 25, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
Not provided
Not provided
Randomised, open-label, allocation concealed, pilot trial
Not provided
Not provided
Group assignment and early (up to 28 day) data will be locked and unavailable to investigators undertaking 6-month follow up.
Not provided
| Usual care strategy | Other | Usual care at the discretion of the clinical team |
|
Incidence of significant protocol violations (total number of patients, per site, and by nature of protocol violation) up to day 5 (intervention period)
| Up to study day 5 |
| Incidence of reported adverse events | Incidence of reported adverse events up to day 5 (intervention period) | 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. | From baseline until day 3 and day 5 |
| Mortality | Mortality | 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) | 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) | 28 days |
| Acute kidney injury | Incidence of new acute kidney injury defined as estimated KDIGO Stage 3 (before and after correction for fluid balance) | Up to day 5. |
| Cognitive function | Cognitive function score (assessed using the Montreal Cognitive Assessment (MoCA-blind) instrument) | 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. | 180 days |
Near infra-red spectroscopic measurement of regional cerebral oxygen saturation), Minimum rScO2 level
| 72 hours from randomisation |
| Regional cerebral hypoxia burden | Near infra-red spectroscopic measurement of regional cerebral oxygen saturation), proportion of time spent with rScO2 below thresholds of 50%, 65%, and 75% as a proportion of the time for which cerebral oxygenation is measured, expressed as a percentage. | 72 hours from randomisation |
| Antrim |
| Northern Ireland |
| United Kingdom |
| Belfast City Hospital | Belfast | Northern Ireland | BT12 6AB | United Kingdom |
| Royal Victoria Hospital | Belfast | Northern Ireland | BT12 6BA | United Kingdom |
| South-Eastern Health and Social Care Trust | Dundonald | Northern Ireland | United Kingdom |
| Sunderland Royal Hospital | Sunderland | Tyne and Wear | United Kingdom |
| Western Health and Social Care Trust | Londonderry | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | United Kingdom |
| Result |
| Silversides 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. |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |