ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000744651

Ethics application status

Approved

Date submitted

3/06/2014

Date registered

14/07/2014

Date last updated

14/07/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

A comparison of the effects of different albumin solutions on severely ill adults in the intensive care unit.

Scientific title

Physiological and Biochemical Responses to Fluid Bolus Therapy with 4% versus 20% Human Albumin Solution in Critically Ill Adults

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical illness

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Intravenous fluid bolus therapy with either 4% or 20% human albumin solution administered according to clinician preference

Intervention code [1]

Not applicable

Comparator / control treatment

Direct comparison of physiological and biochemical parameters following admisnitrations of 4% versus 20% human albumin solutions

Control group

Dose comparison

Outcomes

Primary outcome [1]

Mean arterial pressure

Timepoint [1]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [1]

Hospital mortality

Timepoint [1]

hospital discharge

Secondary outcome [2]

Heart rate

Timepoint [2]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [3]

Systolic blood pressure

Timepoint [3]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [4]

Diastolic blood pressure

Timepoint [4]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [5]

Serum sodium

Timepoint [5]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [6]

serum chloride

Timepoint [6]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [7]

serum base excess

Timepoint [7]

1, 2 and 4 hours post fluid bolus therapy

Secondary outcome [8]

serum creatinine

Timepoint [8]

1, 2 and 4 hours post fluid bolus therapy

Eligibility

Key inclusion criteria

All adult ICU admissions who received either 4% or 20% (but not both) human albumin solution as fluid bolus therapy at our institution between April 2012 and March 2013

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients received both 4% and 20% solution within 24 hours of baseline

2. Patients who had previously received any human albumin solution during their ICU stay

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/2012

Actual

1/11/2012

Date of last participant enrolment

Anticipated

26/02/2013

Actual

26/02/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Prof Rinaldo Bellomo

Address

Dept of Intensive Care,
Austin Health,
145 Studley road,
Heidelberg,
VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Jonathan Bannard-Smith

Address [1]

Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIc 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Local Ethics Committee

Ethics committee address [1]

Office for Research,
Level 8, Harold Stokes Building,
Austin Hospital,
Studley Road,
Heidelberg,
VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/06/2014

Ethics approval number [1]

LNR/14/Austin/313

Summary

Brief summary

Background: Fluid bolus therapy (FBT) is common in critically ill patients. With the exception of traumatic brain injury, FBT with human albumin solution appears safe and perhaps superior in severe sepsis/septic shock patients. However, 4% and 20% albumin solutions have different chloride contents and deliver different volumes.

Objective: To compare the physiological and biochemical effects of FBT with 4% vs. 20% human albumin solution.

Design: Retrospective observational study

Setting: Tertiary intensive care unit

Subjects: Critically ill patients receiving FBT with either 4% or 20% human albumin solution according to clinician preference

Measurements and Main Results: We recorded demographic and clinical data for 202 patients (101 patients in each group). We obtained biochemical and hemodynamic data at baseline and at 1, 2 and 4 hours after the administration of either 4% or 20% human albumin solution. We compared the effect of FBT with the two solutions. Patients receiving 20% albumin had a higher incidence of pre-existing liver disease (P=0.003), were more likely to be on renal replacement therapy (P=0.005) and had higher APACHE III scores and predicted risk of death on admission (P=0.007 and <0.0001 respectively).  Patients in the 4% group received a median volume of 500mls of albumin compared to 100mls in the 20% group (P<0.0001).  There was a trend in higher mean arterial pressure values in the 20% group at 2 and 4 hours following the fluid bolus (P=0.056).  There were no significant differences in absolute or percentage change of any haemodynamic parameters over the four hours following fluid bolus. Patients receiving 4% albumin demonstrated higher serum chloride levels and more negative bass excess (P =0.027 and 0.017, respectively).  The difference in base excess was greater following post-hoc adjustment for risk of death (P=0.003/ 0.004) .  

Conclusions: FBT with 100 ml of 20% human albumin solution is hemodynamically equivalent to FBT with 500 ml of 4% human albumin solution but has a lesser effect on chloride levels and delivers 80% less fluid.

Trial website

Trial related presentations / publications

Public notes

This retrospective study involved the analysis of pre-existing data that is routinely entered into patient records. Local ethics approval has been granted prior to its analysis and write up for publication.

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIC 3084

Country

Australia

Phone

+61 (0)3 9496 5000

Fax

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Rinaldo Bellomo

Address

Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIC 3084

Country

Australia

Phone

+61 (0)3 9496 5000

Fax

rinaldo.bellomo@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIC 3084

Country

Australia

Phone

+61 (0)3 9496 5000

Fax

rinaldo.bellomo@austin.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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