The purpose of this study is the Comparison of intensive versus conventional glycemic control in patients on parentral nutrition (PN) in intensive care unit. In this study, 32 patients 18 years old or older, were participated. Patients had head trauma, GCS 4-9, and received at least half of their needs through PN. Patients with Liver, kidney, heart, pancrease failure and/or diabetes were excluded from the study. Patients were randomly received intensive insulin therapy (continuous infusion) or conventional blood glucose control (12 hours checking). One of the most important results of tight glucose control is severe hypoglycemia that can lead to mortality. In this study, we want to compare intensive with conventional method with a minimal change in infusion chart.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111158108N1
Registration date:2011-12-08, 1390/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-08, 1390/09/17
Registrant information
Name
Neda Mousavi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2103
Email address
kamgarm881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-02-04, 1389/11/15
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intensive versus conventional glycaemic control in patients on parentral nutrition in intensive care unit.
Public title
Comparison of intensive versus conventional glycaemic control in patients on parentral nutrition
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 18 years or older with GCS 4-9 with muscle erosion, diarrhea or high residue that couldn’t feed through oral or enteral rout, were eligible for enrolling into the study. Patients on parentral nutrition criteria received at least 50% of their calorie from parenteral nutrition. Exclusion criteria: Patients with liver; kidney; heart; pancrease failure and or diabetes
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad medical university
Street address
Biochemistry & Nutrition department, faculty of medicine, Mashhad medical university, Khorasan.
City
Mashhad
Postal code
Approval date
2011-01-03, 1389/10/13
Ethics committee reference number
thesis register+ethics:89341
Health conditions studied
1
Description of health condition studied
Hyperglycemia resulted from parenteral nutrition
ICD-10 code
R73.9
ICD-10 code description
Hyperglycaemia, unspecified
Primary outcomes
1
Description
Hyperglycemia
Timepoint
Every 2 hours in tight control group- every 12 hours in conventional group.
Method of measurement
Glucometer Kit.
Secondary outcomes
1
Description
During of hospital and ICU stay, mortality
Timepoint
14 & 28 days after intervention
Method of measurement
Observe & phone number
Intervention groups
1
Description
Intensive control: 50 unit regular insulin in 50 cc saline, continious insulin infusion, blood glucose control every 2 hours and insulin infusion according to chart, administration of this method in 14 days.
Category
Treatment - Drugs
2
Description
Conventional control: blood glucose checking every 12 hours, regular insulin injection according to chart, administration of this method in 14 days.