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Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride

NCT ID: NCT00228657

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-08-31

Brief Summary

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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.

Detailed Description

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Pressure ulcers incur multiple risks to the patient. The disruption of the skin is a portal of entry for infection , which may remain localised to the site or become blood borne. A pressure ulcer can lead to protein and fluid losses from the wound exudate. Many authors have theorised the existence of a relationship between the development of pressure ulcers and low serum albumin levels however, there is no strong evidence to prove this correlation. The literature does demonstrate a clear relationship between people with existing pressure ulcers and the presence of low serum albumins. Specifically serum albumin levels \<30mg/dl have been associated with the incidence of pressure ulcer development.

Conditions

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Pressure Ulcer, Area Pressure Ulcer, Grade Albumin Level Risk Score Length of ICU Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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4% Albumin / 0.9% Sodium Chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Randomisation to the SAFE study -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shena M Graham, BN

Role: PRINCIPAL_INVESTIGATOR

The Alfred Hospital, Prahran, Melbourne, Australia

Locations

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The Alfred Hospital, Prahran,

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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. doi: 10.1046/j.1365-2648.2000.01484.x.

Reference Type BACKGROUND
PMID: 10964183 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 2018614 (View on PubMed)

Cullum N, Clark M. Intrinsic factors associated with pressure sores in elderly people. J Adv Nurs. 1992 Apr;17(4):427-31. doi: 10.1111/j.1365-2648.1992.tb01926.x.

Reference Type BACKGROUND
PMID: 1578064 (View on PubMed)

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. doi: 10.1097/00002727-199205000-00002. No abstract available.

Reference Type BACKGROUND
PMID: 1568151 (View on PubMed)

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. doi: 10.1016/s0272-5231(05)70152-0.

Reference Type BACKGROUND
PMID: 10386267 (View on PubMed)

Kuhn MM. Colloids vs crystalloids. Crit Care Nurse. 1991 May;11(5):37-44, 46-51.

Reference Type BACKGROUND
PMID: 2026044 (View on PubMed)

Other Identifiers

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137/99

Identifier Type: -

Identifier Source: org_study_id