Evaluation of intravenous fluid resuscitation with either 4% albumin or 20% albumin solution for patients admitted to the intensive care unit
A Pilot, Randomised, Unblinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of 20% vs 4% Human Albumin Solution for Fluid Bolus Therapy in Critically Ill Adults
Austin Health
400 participants
Jul 20, 2015
Interventional
Conditions
Summary
Administration fluids directly into a vein is commonly used to treat low blood pressure in critically ill patients, termed fluid resuscitation. The aim of fluid resuscitation is to restore and maintain organ function. Two commonly administered intravenous fluids are 20% albumin and 4% albumin. Intensive care doctors do not known if either of these two fluids should be used in preference to the other for fluid resucitation. In response, the aim of this study is to establish the feasibility, safety, biochemical and physiologicy efficacy of intravenous 20% albumin solution compared with intravenous 4% albumin soluation for fluid bolus therapy in critically ill patients. For a period of 48 hours from enrolment, patients that are enrolled in this study will receive either of the study fluids when their treating intensive care doctors deems it necessary. This study will enrol 400 patients for two intensive care units of hospitals located in Melbourne and Adelailde, Australia. If our findings support one intravnous fluid over the other then we would aim to conduct larger studies to assess its benefits in terms of patient-centred outcomes.
Eligibility
Inclusion Criteria4
- Admitted to the Department of Intensive Care, Austin Hospital for less than 48 hours or to the Intensive and Critical Care Department of the Flinders Medical Centre for less than 48 hours.
- Age 18 years or greater
- Need for fluid bolus as determined by the treating clinician
- Presence of one or more of the following physiological states: systolic BP <90 mmHg, or MAP <65 mmHg, or increasing need for vasopressor drug infusion or pulse pressure variation >12 % or stroke volume variation >12%, or Cardiac index <2.2 L/min/m2 or heart rate >100 or urinary output <20 ml/hr or either rising lactate levels or lactate levels >2 mmol/L or capillary refill time >3 seconds or central venous pressure <8 mmHg.
Exclusion Criteria6
- Confirmed or suspected pregnancy
- Patients with traumatic brain injury
- Active bleeding
- Haemoglobin level <70 g/L
- People who refuse blood products
- Patients in whom death is considered imminent (within 24 hours)
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Interventions
Following blinded allocation, eligible enrolled patients admitted to the intensive care unit will: 1. During the first 48 hrs in intensive care patient to receive intravenous 4% albumin bolus in volumes prescribed as required by their treating intensive care doctor. 2. In the intensive care unit - other intravenous fluids/blood products given as required by their treating intensive care doctor. 3. If patient needs to return to theatre, IV fluids as per treating anaesthetic team. 4. After 48 hrs – bolus fluid therapy as per intensive care unit medical team.
Locations(2)
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ACTRN12615000349549