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Completed

NCT Number: NCT03512392

Role of Active Deresuscitation After Resuscitation-2

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.

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Key information

Conditions

Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Trauma Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aneurin Bevan University Health Board, Newport, Gwent, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Conservative fluid and deresuscitation strategy

Other

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

Usual care strategy

Other

Usual care at the discretion of the clinical team

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cumulative fluid balance

    Time frame: Up to the beginning of days 3 and 5, and at ICU discharge (estimated median day 7)

    Cumulative fluid balance (mL) from ICU admission

  2. Incidence of significant protocol violations

    Time frame: Up to study day 5

    Incidence of significant protocol violations (total number of patients, per site, and by nature of protocol violation) up to day 5 (intervention period)

  3. Incidence of reported adverse events

    Time frame: Up to study day 5

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

  4. Change in Sequential Organ Function Assessment scores

    Time frame: From baseline until day 3 and day 5

    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.

  5. Mortality

    Time frame: 28 and 180 days

    Mortality

  6. Duration of mechanical ventilation

    Time frame: 28 days

    Duration of mechanical ventilation in survivors and non-survivors (number of days or part thereof from initiation of mechanical ventilatory support until unassisted breathing)

  7. Length of ICU stay

    Time frame: 28 days

    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)

  8. Acute kidney injury

    Time frame: Up to day 5.

    Incidence of new acute kidney injury defined as estimated KDIGO Stage 3 (before and after correction for fluid balance)

  9. Cognitive function

    Time frame: 180 days

    Cognitive function score (assessed using the Montreal Cognitive Assessment (MoCA-blind) instrument)

  10. Health-related quality of life

    Time frame: 180 days

    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.

Other outcomes

  1. Mean regional cerebral oxygen saturation

    Time frame: 72 hours from randomisation

    Near infra-red spectroscopic measurement of regional cerebral oxygen saturation), mean rScO2 level (%)

  2. Minimum regional cerebral oxygen saturation

    Time frame: 72 hours from randomisation

    Near infra-red spectroscopic measurement of regional cerebral oxygen saturation), Minimum rScO2 level

  3. Regional cerebral hypoxia burden

    Time frame: 72 hours from randomisation

    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.

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

  • Queen's University, Belfast
  • University of Toronto

Registry information

Official study title

Role of Active Deresuscitation After Resuscitation- 2: a Pilot Randomised Controlled Trial of Conservative Fluid Management Versus Usual Care in Critical Illness

Acronym: RADAR-2

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 30, 2018
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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