Assessment the effect of enteral feeding riched with wheat germ on weaning from mechanical ventilatory of patients admitted to intensive care unit of Urmia Imam Khomeini Hospital
To determine the effect of enteral feeding enriched with wheat germ on weaning from mechanically ventilated of patients admitted to the intensive care unit
Design
Single-blind, Randomized clinical trial
Settings and conduct
100 patients undergoing mechanical ventilation in the intensive care unit of Urmia Imam Khomeini Hospital will be randomly assigned to the intervention or control group. enteral feeding for both groups will begin in the first 24 hours of admission. Additionally, patients in the intervention group will receive the 40% fat, 45% carbohydrate, 15% protein, and enriched with 100 grams of wheat germ. the control group will receive the Blenderized with 30% fat, 50% carbohydrate and 20% protein. The variables of study will be measured at baseline and weekly in both groups. The duration of the intervention will be from the first day of admission until weaning from the ventilator mechanical.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mechanically ventilated patients admitted to the intensive care unit; age 65-18 years, patients with a minimum length of stay 7 days.
Exclusion criteria: Patients with Parenteral Feeding; Having chronic and acute renal failure; patients under Hemodialysis or peritoneal dialysis.
Intervention groups
The intervention group will receive the Blenderized of 40% fat, 45% carbohydrate, 15% protein and enriched with 100 grams of wheat germ.
the control group will receive 30% fat, 50% carbohydrates, and 20% protein.
Main outcome variables
Duration of mechanical ventilation; duration of hospitalization in ICU; mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171221037983N3
Registration date:2018-05-16, 1397/02/26
Registration timing:registered_while_recruiting
Last update:2018-05-16, 1397/02/26
Update count:0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
Mohammad Amin Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
valizademohammadamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of enteral feeding riched with wheat germ on weaning from mechanical ventilatory of patients admitted to intensive care unit of Urmia Imam Khomeini Hospital
Public title
The effect of enteral feeding on weaning of mechanical ventilation patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under mechanical ventilation in intensive care units
age 18-65 years
Patients with a minimum length of stay 7 days
Exclusion criteria:
Patients with Par-enteral Feeding
Patients with chronic and acute renal failure
Patients under hemodialysis or peritoneal dialysis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly will divide into two intervention or control groups. using random numbers table, a number will select as randomly. Patients will be assigned to the intervention or control groups according to the last number of medical records. The pair and Odd numbers will enroll in the intervention and control group, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be unaware of assign in the intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences