Role of Active Deresuscitation After Resuscitation-2

Belfast Health and Social Care Trust180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Critical Illness Sepsis Trauma

Interventions

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

Day 3 fluid balance

Change in fluid balance (mL) between the beginning of study day 2 and the beginning of study day 3.

Time frame: From beginning of day 2 to the beginning of study day 3.

Secondary Outcomes

Cumulative fluid balance

Cumulative fluid balance (mL) from ICU admission

Time frame: 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)

Time frame: Up to study day 5

Incidence of reported adverse events

Incidence of reported adverse events up to day 5 (intervention period)

Time frame: 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.

Time frame: From baseline until day 3 and day 5

Mortality

Time frame: 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)

Data from ClinicalTrials.gov

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