ACTRN12615000349549CompletedPhase 4
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
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Austin Health
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1. 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.
- •2. Age 18 years or greater
- •3. Need for fluid bolus as determined by the treating clinician
- •4. 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 Criteria
- •1. Confirmed or suspected pregnancy
- •2. Patients with traumatic brain injury
- •3. Active bleeding
- •4. Haemoglobin level <70 g/L
- •5. People who refuse blood products
- •6. Patients in whom death is considered imminent (within 24 hours)
Investigators
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