Comparison between total parenteral nutrition (TPN) Vs. partial parenteral nutrition (PPN) on serum lipids among chronic ventilator dependent patients, A multi center study
The goal of this study is evaluation of two nutrition methods in chronic ventilator support patients in ICU. (TPN and PPN)
Other goals includes: comparison of serum total protein
Comparison of serum albumin
Comparison of serum transferrin
Comparison of serum total lymphocyte count
Design is a prospective randomized double blind controlled clinical trial as a multi-center study. 97 patients enter the study and divide in to two groups according the inclusion criteria. Serum total protein, serum albumin, serum transferring and total lymphocyte count are measured at days 7 and 14.
Inclusion criteria: chronically need to ventilatory support more than 10 days and ages between 40 to 70 and respiratory disease
Exclusion: Weaning before one week
TPN (Total Parenteral Nutrition): begin from central vein after all inclusion criteria.
PPN (Partial Parenteral Nutrition): begin after calculating total energy needs for each patients by dividing total calorie intake equally between enteral and parenteral nutrition and if gastric secretion are less than 100 ml during 2 hours and bowel sounds are heard.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505247457N14
Registration date:2015-12-24, 1394/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Shabnam Golshan
Name of organization / entity
Urology and Nephrology Research Center (UNRC)
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
shgolshan@unrc.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-12-31, 1391/10/11
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between total parenteral nutrition (TPN) Vs. partial parenteral nutrition (PPN) on serum lipids among chronic ventilator dependent patients, A multi center study
Public title
comparing two methods of nutrition in ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: chronic ventilator supported patients in ICU more than 10 days
Age: 40 to 70
Respiratory disease
exclusion: ventilator supported patients that wean before one week
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
97
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shaheed Beheshti University of Medical science
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin , Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
1746/م/الف
Health conditions studied
1
Description of health condition studied
chronic patient under mechanical ventilation
ICD-10 code
E64
ICD-10 code description
Sequelae of malnutrition and other nutritional deficiencies