Evaluation of intravenous fluid resuscitation with either 4% albumin or 20% albumin solution for patients admitted to the intensive care unit

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000349549
• Date of registration: 17/04/2015
• Prospective Registration: Yes
• Primary sponsor: Austin Health
• Public title: Evaluation of intravenous fluid resuscitation with either 4% albumin or 20% albumin solution for patients admitted to the intensive care unit
• Scientific title: 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
• Date of first enrolment: 20/07/2015
• Target sample size: 400
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000349549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: A/Prof Glenn Eastwood

• Name: Prof Rinaldo Bellomo

Key inclusion & exclusion criteria

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)


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Low blood volume states;Critical illness;
Low blood volume states
Critical illness

Cardiovascular - Other cardiovascular diseases

Intervention(s)

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.

Primary Outcome(s)

Administered volume of fluid for resuscitation as per the patient's daily fluid balance chart.[During the first 48 hours following randomisation]

Secondary Outcome(s)

Cumulative volume of intravenous vasoactive medication as per the patient's daily fluid balance chart.[Administered over the first forty-eight hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Total volume of intravenous fluids received by the patient as per the patient's daily fluid balance chart.[Administered in the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Total volume of intravenous fluids as per the patient's daily fluid balance chart.[Administered in the first forty-eight hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Relative change in blood pressure variables data[Occuring over the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Relative change between baseline and peak serum creatinine[Over the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Volume of intravenous vasoactive medication as per the patient's daily fluid balance chart.[Administered over the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Relative change in arterial blood gas data[Occuring over the first forty-eight hours after the initial fluid resuscitation bolus with albumin following enrolment.]

Cumulative fluid balance as per the patient's daily fluid balance chart.[Over the first 48 hours following randomisation]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Austin Hospital

Secondary Sponsor(s)

Professor Rinaldo Bellomo

Ethics review

Status: Approved
Approval date:
Contact:

Austin Health Human Research Ethics Committee