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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00228657




Registration number
NCT00228657
Ethics application status
Date submitted
28/09/2005
Date registered
29/09/2005
Date last updated
27/11/2013

Titles & IDs
Public title
Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride
Scientific title
The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)
Secondary ID [1] 0 0
137/99
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure Ulcer, Area 0 0
Pressure Ulcer, Grade 0 0
Albumin Level 0 0
Risk Score 0 0
Length of ICU Stay 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 4% Albumin / 0.9% Sodium Chloride

Treatment: Drugs: 4% Albumin / 0.9% Sodium Chloride


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Is there a difference in the incidence of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Is there a difference in the severity of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
Randomisation to the SAFE study -
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In addition to the SAFE exclusion criteria, pre-existing pressure ulcers (developed prior
to ICU admission) will also be excluded-

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
The Alfred Hospital, Prahran, - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients resuscitated with 4% Albumin will have less incidence and reduced severity of
pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved
intravascular oncotic pressure effected from higher albumin levels.
Trial website
https://clinicaltrials.gov/show/NCT00228657
Trial related presentations / publications
Anthony D, Reynolds T, Russell L. An investigation into the use of serum albumin in pressure sore prediction. J Adv Nurs. 2000 Aug;32(2):359-65.
Hanan K, Scheele L. Albumin vs. weight as a predictor of nutritional status and pressure ulcer development. Ostomy Wound Manage. 1991 Mar-Apr;33:22-7.
Cullum N, Clark M. Intrinsic factors associated with pressure sores in elderly people. J Adv Nurs. 1992 Apr;17(4):427-31.
Goodrich C, March K. From ED to ICU: a focus on prevention of skin breakdown. Crit Care Nurs Q. 1992 May;15(1):1-13.
Peerless JR, Davies A, Klein D, Yu D. Skin complications in the intensive care unit. Clin Chest Med. 1999 Jun;20(2):453-67, x. Review.
Matthewson M. Colloids vs. crystalloids. Critical Care Nurse. Vol 11 (5), 1985
Public notes

Contacts
Principal investigator
Name 0 0
Shena M Graham, BN
Address 0 0
The Alfred Hospital, Prahran, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications