Burn resuscitation and its management is the area of great controversies and among these, there is a continuing challenge about albumin administration and it's beneficial or detrimental effect on mortality, multi organ failure, edema, wound healing and hospital stay. We designed a new study in our burn center for evaluation of albumin administration effects on burn wound healing, hospital stay duration, weight change and mortality. From January 2005 to May 2007, 140 adult female patients with 20% to 40% TBSA burn admitted in Ghotbeddin burn hospital in Shiraz were randomized into two groups, using random allocation software. Patients with respiratory burn were excluded. First group received high protein diet and second group received intravenous albumin supplementation of 20% albumin solution form a single provider company with amount of 1 gr/kg/day after the first 24 hours of burn in addition to high-protein diet. Patients who developed severe hypoalbuminemia (serum albumin <1.5gr/dl) in control group, were excluded from the study and IV albumin supplement started for them. Weight, serum albumin, serum total protein and transferrin levels were checked for the patients at second day of hospitalization (before starting IV albumin) and then weekly to the end of hospitalization. Healing time considered the length of time needed to the wound surface be ready for graft or completely healed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802141605N3
Registration date:2009-05-16, 1388/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-16, 1388/02/26
Registrant information
Name
Ali Akbar Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6097
Email address
mohamadiaa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research
Expected recruitment start date
2005-01-01, 1383/10/12
Expected recruitment end date
2007-06-30, 1386/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Parenteral albumin therapy in patients with extensive Burn
Public title
Parenteral albumin therapy in patients with extensive Burn
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: adult female patients with 20% to 40% TBSA burn Exclusion criteria: Presence of multiple trauma, presence of comorbid diseases, presence of significant inhalation injury, need to intensive care
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences,Ghotb-eddin Burn Center
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Approval date
2007-02-05, 1385/11/16
Ethics committee reference number
CT-86-2363
Health conditions studied
1
Description of health condition studied
Effect of albumin on burn wound healing
ICD-10 code
E64.0
ICD-10 code description
Sequelae of protein-energy malnutrition
Primary outcomes
1
Description
Length of hospital stay
Timepoint
weekly to the end of hospitalization
Method of measurement
Number of admission days
2
Description
Weight change
Timepoint
weekly to the end of hospitalization
Method of measurement
Percentage of change in patient's weight
3
Description
Healing time
Timepoint
weekly to the end of hospitalization
Method of measurement
Time needed to more than 80% of the wound surface be ready for graft or completely healed
Secondary outcomes
empty
Intervention groups
1
Description
Intravenous albumin supplementation of 1 gr/kg/day, 20% albumin solution after the first 24 hour of burn in addition to high-protein diet
Category
Other
2
Description
High protein diet
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghotb-eddin Burn Center
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
Vice-chanceller for Research
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Assistant Professor, General Surgeon
Full name of responsible person
Ali Akbar Mohammadi
Position
Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Phone
+98 71 1821 9638
Fax
+98 71 1821 7090
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
Assistat professor, General Surgeon
Other areas of specialty/work
Street address
Fakhrabad Street, Shiraz
City
Shiraz
Postal code
71638-54733
Phone
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)