comparative clinical outcome in Hypocaloric vs. Fullcaloric Enteral feeding during the first week of Hospitalization in Intensive Care Unite Patients
Design
The present study will be conducted on 126 patients admitted to Shahid Kamyab (Emdadi Hospital) intensive care unit. patients will be under randomly assigned Stratified blocked randomization (RCT) and will divide to two groups, hypocaloric and fullcaloric diet.
Settings and conduct
The present study is a Randomized double-blind controlled trial on 126 patients admitted to Shahid Kamyab (Emdadi Hospital) intensive care unit
Participants/Inclusion and exclusion criteria
Entrance criteria include: adult patients, 18 to 65 y old that expected to Hospitalization in Intensive Care Unite Patients for at least 94 hours and cannot eat sufficiently
exclusion criteria include: mechanical ventilation and body mass index (BMI) <18
Intervention groups
Patients are divided in two groups (63 Patients in each group). after initiation of hemodynamic status during the first 24-48 hours of onset of intestinal nutritional support, patients will be under bolus enteral nutrition each three hours (6 times per 24 hours). In the hypocaloric diet group, 40% of calculated calorie in the first 24-48 hours of admission is given and is given in 100% of a week, and full calorie diet group will receive 100-80% of calculated calorie in the first 24-48 hours of admission
Main outcome variables
Primary outcomes: Anthropometric and metabolic factors. Secondary outcomes: Hospital length of stay, 28 day mortality, severity of disease, Duration of mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120525009856N6
Registration date:2018-03-26, 1397/01/06
Registration timing:prospective
Last update:2018-03-26, 1397/01/06
Update count:0
Registration date
2018-03-26, 1397/01/06
Registrant information
Name
Yahya Pasdar
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 1991
Email address
yahya.pasdar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-30, 1397/01/10
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative clinical outcome in Hypocaloric vs. Fullcaloric Enteral feeding during the first week of Hospitalization in Intensive Care Unite Patients
Public title
The effect of calorie intake on Intensive Care Unite patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with expected length of hospitalization in Intensive Care Unite for at least 94 hours
adult patients, 18 to 65 y old
cannot eat sufficiently
Exclusion criteria:
body mass index (BMI) less than 18.5
mechanical ventilation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be divided into two groups of hypocaloric and full-calorie diet by using Stratified blocked randomization, so that two groups will not have a significant difference in terms of gender, age, body mass index and severity of illness.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blinded method will be used in order to prevent incidence of information bias, in such a way that after calculating required energy for patient, a code will be given to the subject. Afterwards, the patient will be enter into one of the two groups of intervention and control group, based on the attained code through randomized classified method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
IR.KUMS.REC.1396.624
Health conditions studied
1
Description of health condition studied
Patients of intensive care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Aspartate amino transferase
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Spectrophotometer
2
Description
Alanine amino transferase
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Spectrophotometer
3
Description
Reactive Protein C
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Autoanalyser
4
Description
High density lipoprotein
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
HDL kit
5
Description
Triglyceride
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
kit TG
6
Description
Cholesterol
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Cholesterol Kit
7
Description
Low density lipoprotein
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Calculate with Friedewald formula
8
Description
Evaluation of electrolytes (sodium, potassium, magnesium, phosphorus)
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Electrolyte analyzer
9
Description
Fasting blood sugar
Timepoint
Every day for two weeks
Method of measurement
Avtanalizer device
10
Description
Multinational defect
Timepoint
Time intervals 24, 48, 96 hours and the end of intervention
Method of measurement
Sofa questionnaire
Secondary outcomes
1
Description
Insulin received
Timepoint
Every day for two weeks
Method of measurement
questionnaire
2
Description
Infection rate
Timepoint
Followed for 28 days
Method of measurement
questionnaire
3
Description
Duration of ventilator dependence
Timepoint
Followed for 28 days
Method of measurement
questionnaire
4
Description
mortality
Timepoint
Followed for 28 days
Method of measurement
questionnaire
5
Description
Number of hospital admissions days in the intensive care unit
Timepoint
Followed for 28 days
Method of measurement
questionnaire
6
Description
Number of hospital admissions days
Timepoint
Followed for 28 days
Method of measurement
questionnaire
7
Description
Digestive complications
Timepoint
Every day for two weeks
Method of measurement
questionnaire
8
Description
Gastrointestinal intolerance
Timepoint
Every day for two weeks
Method of measurement
questionnaire
9
Description
Calorie intake
Timepoint
Every day for two weeks
Method of measurement
questionnaire
10
Description
Percentage of protein intake
Timepoint
Every day for two weeks
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive Hypocaloric diet. After hemodynamic stabilization, enteral nutrition support will be started during the first 24-48 hours that individual will be inpatient, and will be prescribed in form of bolus every three hours (6 times in 24 hours). Subjects of hypocaloric diet group will receive 40 percent of calculated calorie by using indirect calorimetry device during the first 24-48 hours of being in patient, and this amount will be reach to100 percent of patient’s need in one week. This group will be fed exactly similar to control group by full-calorie method after 7 days of intervention.
Category
Treatment - Other
2
Description
Patients of first group that defined as control group, which is the full-calorie group, will receive 80 to 100 percent of their actual energy requirement as nutrition support in form of enteral method that will be started during the first 24-48 hours of being inpatient. The required calorie will be calculated through indirect calorimetry and intervention will be continued for 7 days