Role of Active Deresuscitation After Resuscitation-2

NCT ID: NCT03512392

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2021-07-17

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conservative fluid and deresuscitation

• 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

Group Type: EXPERIMENTAL

Conservative fluid and deresuscitation strategy

Intervention Type: OTHER

Conservative administration of intravenous fluid and active deresuscitation using diuretics or renal replacement therapy for eligible patients

Usual care

Usual care at the discretion of the treating team

Group Type: ACTIVE_COMPARATOR

Usual care strategy

Intervention Type: OTHER

Usual care at the discretion of the clinical team

Interventions

Conservative fluid and deresuscitation strategy

Conservative administration of intravenous fluid and active deresuscitation using diuretics or renal replacement therapy for eligible patients

Intervention Type: OTHER

Usual care strategy

Usual care at the discretion of the clinical team

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Invasive mechanical ventilation

2. Treating ICU doctor expects patient to require treatment in an ICU beyond the next calendar day

3. Between 24 and 48 hours from ICU admission at the time of randomisation

Exclusion Criteria

1. Age < 16 years

2. Body weight <40kg (measured or estimated)

3. Diabetic ketoacidosis or Hyperosmolar hyperglycaemic state

4. Non-traumatic subarachnoid haemorrhage

5. Acute cardiac failure or cardiogenic shock

6. End-stage renal failure (on dialysis)

7. Known to be pregnant

8. Suspected or proven active diabetes insipidus (DDAVP within 24 hours)

9. Not expected to survive for 72 hours

10. Active 'Do not attempt resuscitation' order

11. Refusal of consent

12. Inability of personal consultee to understand written or verbal information and for whom no interpreter is available

13. Known allergy to one or more of the study drugs

14. Inability to measure fluid balance

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Belfast Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Silversides, MB BCh

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Locations

Aneurin Bevan University Health Board

Newport, Gwent, United Kingdom

Northern Health and Social Care Trust

Antrim, Northern Ireland, United Kingdom

Belfast City Hospital

Belfast, Northern Ireland, United Kingdom

Royal Victoria Hospital

Belfast, Northern Ireland, 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

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 27734109 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34913089 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

17057JS-AS

Identifier Type: -

Identifier Source: org_study_id