1. Home
  2. Approved trials
  3. » فارسی

The effect of continuous feeding on nutritional status of hospitalized patients with multiple trauma in ICU of Taleghani hospital

Protocol summary

Summary
Objective: to determine the effect of continuous feeding on nutritional status of patients with multiple trauma in ICU of Taleghani hospital, Design of study: randomaized, Population: patients with multiple trauma, Major inclusion criteria: having multiple trauma including head trauma, body mass index between 18.5 to 29.5, and no need to specific diet (such as diabetes and hypertension), Major exclusion criteria: catching a disease requiring a specific diet during the study period, discharging or passing out before the seventh day of the study, Sample size:60 patients, Intervention: there are three different intervention methods including continuously feeding through the infusion pump, intermittent feeding through the nasogastric tube, and intravenous feeding, Time of intervention: in continuous feeding, the patients will be fed every 8 hours (20ml/hr); In the intermittent method, the patients will be fed once every three hours about 15 minute; and daily with intravenous solutions in the intravenous method, Primary outcomes: changing in weight, results of blood tests (such as albumin and ferritin).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011194736N2
Registration date: 2010-12-18, 1389/09/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-12-18, 1389/09/27
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research & technology, Kermanshah university of medical sciences
Expected recruitment start date
2010-11-23, 1389/09/02
Expected recruitment end date
2011-03-11, 1389/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous feeding on nutritional status of hospitalized patients with multiple trauma in ICU of Taleghani hospital
Public title
The effect of continuous feeding on nutritional status of multiple trauma patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with diagnosis of multiple trauma associated with head trauma, body mass index between 18.5 to 29.5, does not need to specific diet (such as diabetes, hypertension, hyprlipidemia, renal failure, liver failure, heart failure, AIDS , cancer , etc), not receiving food orally or intravenously at the beginning of feeding Exclusion criteria: catching diseases requiring a specific diet during the study period, discharge or the patient died before the seventh day of study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic commitee of kermanshah university of medical sciences
Street address
Shahid beheshty blv.
City
Kermanshah
Postal code
Approval date
2010-09-06, 1389/06/15
Ethics committee reference number
6217/420/7/پ

Health conditions studied

1

Description of health condition studied
Nutritional status
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Albumin
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

2

Description
Nitrogen balance
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

3

Description
Total protein
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

Secondary outcomes

1

Description
Iron, serum
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

2

Description
Creatinine height index (CHI)
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

3

Description
Urea, serum
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

4

Description
Total iron binding capacity
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

5

Description
Ferritin
Timepoint
At admission time and then at the end of first, second and third weeks after admission
Method of measurement
Laboratory methods

Intervention groups

1

Description
The intermittent feeding group will be fed intermittently once every three hours about 15 minute by nasogastric tube.
Category
Prevention

2

Description
In intervention group, patient will be fed every 8 hours (20ml/hr) using continuous infusion pump.
Category
Prevention

3

Description
The intravenous feeding group includes patients who after several days of receiving intermittent feeding will be fed intravenously as doctor order.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghany hospital
Full name of responsible person
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Dr Farid Najafy
Street address
Sepah pasdaran sq, shahid beheshty bld.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah university of medical sciences
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
Kermanshah school of nursing and midwifery
Full name of responsible person
Alireza Khatony
Position
PhD. dean of faculty
Other areas of specialty/work
Street address
Doolat abbad, ashayer bld.
City
Kermanshah
Postal code
Phone
+98 83 1827 9394
Fax
Email
akhatony@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah school of nursing and midwifery
Full name of responsible person
Alireza Khatony
Position
Phd- dean of faculty
Other areas of specialty/work
Street address
Dolaat abad, ashayer bld
City
Kermanshah
Postal code
Phone
+98 83 1827 9394
Fax
Email
akhatony@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
kermanshah school of nursing and midwifery
Full name of responsible person
Alireza Khatony
Position
PhD-faculty member, dean of faculty
Other areas of specialty/work
Street address
Doolat aba'd, ashayer bld.
City
kermanshah
Postal code
Phone
+98 82 79394
Fax
Email
akhatony@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...