The high prevalence of malnutrition and related problems In intensive care unit patients and controversial results in administration of intravenous albumin in this patients. This study is designed to determine the effect of intravenous albumin on the level of human visceral proteins in hospitalized patients in intensive care units, and the results of this study determined the efficiency of intravenous albumin to reduce malnutrition. This study is a randomized double-blind placebo-trials is done in the intensive care units. Inclusion criteria are adult patients with serum albumin less than 3.5 g/dl who endure the volume of gastric antral support at least 200 cc /3hr and have a minimum of 24 hours of ICU stay. Exclusion criteria are patients with enteral feeding intolerance up to 48 hours, patients with kidney and liver disease and any underlying medical condition that is associated with protein loss are excluded. After the final selection, participants were randomly divided into two groups; 1) intravenous human albumin supplement of 20 mg per day with a normal diet and 2) high protein diet + placebo. The period of the study is at least 6 days , and biochemical variables like serum albumin, pre-albumin, CRP levels were measured weekly throughout the project from beginning to end.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013073013160N3
Registration date:2013-11-03, 1392/08/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-03, 1392/08/12
Registrant information
Name
Shima Dehghan
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 5453
Email address
sh.dehghan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-01-15, 1392/10/25
Expected recruitment end date
2014-07-16, 1393/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of parentral human albumin on visceral proteins in critical patients
Public title
Effect of parentral albumin on nutrition status in critical patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: adult patients; serum albumin less than 5/3 g per deciliter; have the power and volume of gastric antral support at least 200 cc every 3 hours; a minimum of 24 hours of ICU stay and not take part in another trial research. Exclusion criteria: patients with feeding intolerance antral; antral power outages up to 48 hours; patients with kidney disease; liver disease and any underlying medical condition that is associated with protein loss are excluded. Patients who change the way they eat or be transferred to other centers throughout the city are also excluded.
Age
From 20 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoghi University of Medical Science
Street address
bahonar square- yazd
City
yazd
Postal code
8944157963
Approval date
2013-10-21, 1392/07/29
Ethics committee reference number
141748
Health conditions studied
1
Description of health condition studied
Protein-energy malnutrition
ICD-10 code
E43
ICD-10 code description
Unspecified severe protein-energy malnutrition
Primary outcomes
1
Description
prealbummin
Timepoint
weekly
Method of measurement
blood sample. mg/dl
2
Description
serum albumin
Timepoint
weekly
Method of measurement
blood sample. mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
control group:high protein diet daily through Mifflin - Benedict is calculated and two vials of albumin placebo.
Category
Treatment - Drugs
2
Description
Intervention group: intravenous administration of human albumin 20% of physicians daily 2 vials Shhr Darou company received a normal diet under standard formula for calculating the Harris - Benedict are
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnamoon hospital
Full name of responsible person
Dr. Ali Ghadami
Street address
shahid rahnamoon hospital-farokhi street-yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Mohammad Hossein Jarrahzade
Street address
bahonar square-yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi University of Medical Science
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
Yazd Shahid Sadoughi University of Medical Science
Full name of responsible person
Shima Dehghan
Position
MSc student
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Science-daneshjoo blv- yazd
City
Yazd
Postal code
Phone
+98 35 1822 9845
Fax
Email
shimadehghan_84@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Science
Full name of responsible person
Shima Dehghan
Position
MSc student
Other areas of specialty/work
Street address
daneshjoo Boulevard- yazd
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
Email
shimadehghan_84@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)