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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] 284726 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 292075 0
Condition category
Condition code
Other 292414 292414 0 0
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] 289509 0
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] 292612 0
Mean arterial pressure
Timepoint [1] 292612 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [1] 308615 0
Hospital mortality
Timepoint [1] 308615 0
hospital discharge
Secondary outcome [2] 309330 0
Heart rate
Timepoint [2] 309330 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [3] 309331 0
Systolic blood pressure
Timepoint [3] 309331 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [4] 309332 0
Diastolic blood pressure
Timepoint [4] 309332 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [5] 309333 0
Serum sodium
Timepoint [5] 309333 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [6] 309334 0
serum chloride
Timepoint [6] 309334 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [7] 309335 0
serum base excess
Timepoint [7] 309335 0
1, 2 and 4 hours post fluid bolus therapy
Secondary outcome [8] 309336 0
serum creatinine
Timepoint [8] 309336 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2540 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 8222 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289343 0
Self funded/Unfunded
Name [1] 289343 0
Address [1] 289343 0
Country [1] 289343 0
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] 288028 0
None
Name [1] 288028 0
Address [1] 288028 0
Country [1] 288028 0
Other collaborator category [1] 277987 0
Individual
Name [1] 277987 0
Dr Jonathan Bannard-Smith
Address [1] 277987 0
Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIc 3084
Country [1] 277987 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291113 0
Local Ethics Committee
Ethics committee address [1] 291113 0
Office for Research,
Level 8, Harold Stokes Building,
Austin Hospital,
Studley Road,
Heidelberg,
VIC 3084
Ethics committee country [1] 291113 0
Australia
Date submitted for ethics approval [1] 291113 0
Approval date [1] 291113 0
28/06/2014
Ethics approval number [1] 291113 0
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 48914 0
Prof Rinaldo Bellomo
Address 48914 0
Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIC 3084
Country 48914 0
Australia
Phone 48914 0
+61 (0)3 9496 5000
Fax 48914 0
Email 48914 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 48915 0
Prof Rinaldo Bellomo
Address 48915 0
Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIC 3084
Country 48915 0
Australia
Phone 48915 0
+61 (0)3 9496 5000
Fax 48915 0
Email 48915 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 48916 0
Prof Rinaldo Bellomo
Address 48916 0
Dept of Intensive Care,
Austin Health,
145 Studley Road,
Heidelberg,
VIC 3084
Country 48916 0
Australia
Phone 48916 0
+61 (0)3 9496 5000
Fax 48916 0
Email 48916 0
rinaldo.bellomo@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary