A comparison of the effect of receiving albumin in the initial 8 to 12 hours and after 24 hours after burn on the incidence of fluid creep in severe burn patients
comparing the effect of receiving albumin in the first 8-12 hours or after 24 hours after burning on the incidence of fluid creep in severe burn patients
Design
The study is a randomized triple-blinded controlled clinical trial with a parallel design. This study will use block randomization. A sample size of 96 participants will be classified according to burn percent and the existence of inhalation injury, and in each group, patients will be randomized into either intervention or control group according to 2 or 4 randomized blocks.
Settings and conduct
The study will be done in velayat burn hospital, Rasht. The triple-blind study design will be used, blinding patients, outcome assessment team, and data analyst.
Participants/Inclusion and exclusion criteria
severe burn patients
patients not needing albumin infusion according to the clinical decision of specialists, critically ill patients, patients with underlying conditions affecting serum albumin level or study outcomes, and patients with a history of response to human albumin will be excluded from the study.
Intervention groups
The intervention group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn between 8 to 12 hours after admission as a 1-hour infusion. The control group will receive the same amount of albumin after 24 hours post-admission.
A comparison of the effect of receiving albumin in the initial 8 to 12 hours and after 24 hours after burn on the incidence of fluid creep in severe burn patients
Public title
An evaluation of the effect of albumin administration time on the incidence of fluid creep in severe burn patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
burn patients with 2nd and 3rd degree burn area more than 20 percent TBSA
full-thickness burn area more than 10 percent TBSA
patients needing vasopressor usage in the first 24 hours of admission
patients needing intubation and mechanical ventilation in the first 24 hours of admission
Exclusion criteria:
patients not needing albumin infusion according to the clinical decision of specialist
critically ill patients with expected death in first 24 hours or patients that expired in first 24 hours of admission
brain death in first 24 hours
patients admitted more than 8 hours after burn
patients with chronic underlying diseases affecting serum albumin level, including nephrotic syndrome, cirrhosis, malnutrition, exudative enteropathy
pregnancy
a history of cardiac surgery or myocardial infarction in recent 5 years
patients with high-voltage electrical burn injuries
patient does not accept entering the study
patients receiving plasmaphresis
a history of reaction to human albumin
Age
From 1 year old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In the presenting study, we employ categorized randomization. We classify the minimum sample size according to the existence of inhalation injury and burn surface area. To randomize the patients into intervention and control groups, we use restricted randomization with block randomization. We use randomized 2 or 4 member blocks to prevent revealing the last allocation in each block. Patients entering the study after completion of each block will enter new 2 or 4 member blocks.
We classify patients according to burn surface area into 5 groups with 20-25, 25-30, 30-35, 35-40, and more than 40 percent total body surface area burn, and regarding inhalation injury into 2 groups having or not having inhalation injury.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Albumin will be infused into the patient's resuscitation fluids and the patient is not going to be aware of the time of albumin infusion. Data collection is done by observing team members that are not aware of the patient's allocation to either intervention or control groups, using the designed checklist. Data analysis is performed by the specialist that is not aware of A and B coding (and that which one is the intervention group).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Guilan university of medical sciences
Street address
Deputy of Research and Technology of Guilan University of Medical Sciences, Siyadati St., Namjou Blvd., Rasht
City
Rasht
Province
Guilan
Postal code
3369741938
Approval date
2021-06-02, 1400/03/12
Ethics committee reference number
IR.GUMS.REC.1400.085
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
Primary outcomes
1
Description
fluid creep, patient's fluid intake exceeding estimated intake with parkland formula
Timepoint
12 hours and 1,2,3,5, and 7 days after-burn
Method of measurement
assessment of the fluid intake of patient to maintain a satisfactory urine output
Secondary outcomes
1
Description
Length of hospital stay
Timepoint
At the time of hospital discharge
Method of measurement
Days
Intervention groups
1
Description
Intervention group: The intervention group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn between 8 to 12 hours after admission as a 1-hour infusion.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn after 24 hours post-admission as a 1-hour infusion.