Protocol summary

Summary
The aim of this study was to compare the effects of enteral feeding through bolus method and continuous method on blood sugar and pre albumin level among ICU inpatients in 2013. Fifty subjects were selected by convenient sampling in ICU wards of Alzahra hospital, Isfahan, Iran and randomly assigned to two groups of study and control in this clinical trial. The subjects in study received infusion pump feeding while the control group received bolus feeding for 72hr. Blood sugar was checked each four hr for 72 hr and pre albumin was assessed on the first and the fourth day in two groups. In study group, mean blood sugar significantly decreased on the fourth day, compared to the first, and the third day.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020220912N1
Registration date: 2015-04-06, 1394/01/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-06, 1394/01/17
Registrant information
Name
Mohsen Shahriari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2915
Email address
shahriari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-06-19, 1392/03/29
Expected recruitment end date
2013-10-17, 1392/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Enteral Feeding Through Bolus and Continuous Method on Physiologic and Mtabolic Criteria in ICU Patients
Public title
Nutrition Support in ICU Ward Inpatients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:unable to swallow food orally; had the possibility of bolus or continuous feeding methods; had similar indications for both methods; had no fistula, necrosis or obstruction in intestinal; had not surgery of gastrointestinal system; had not peritonitis and diabetes. Exclusion criteria: discharge or death before 72 hr; change in clinical situation; no interest for continues in research.
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: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjrib Ave.
City
Isfahan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
390458

Health conditions studied

1

Description of health condition studied
Symptoms and signs concerning food and fluid intake
ICD-10 code
R63.6
ICD-10 code description
Insufficient intake of food and water due to self neglect

Primary outcomes

1

Description
Blood Suger, Prealbumine
Timepoint
First Day, Second Day, Third Day, Fourth Day
Method of measurement
Blood Sample

Secondary outcomes

1

Description
Gastric Functional Residual Volume
Timepoint
First Day, Second Day, Third Day, Fourth Day
Method of measurement
Gastric residual volume Measurment

Intervention groups

1

Description
control group: Bolus feeding by 1 kcal per ml of Enshure solution using a syringe applied every 4 hours.
Category
Other

2

Description
intervention group: continues feeding by 1 kcal per ml of Enshure solution using a pump applied in 24 hours.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Alzahara Hospital
Full name of responsible person
Mohsen Shahriari
Street address
ICU Ward, Alzahara Hospital, Sofheh Ave.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Street address
Isfahan University of Medical Sciences, Hezarjrib Ave.,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Position
Associated professor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2915
Fax
Email
shahriari@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Position
Associater professor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2915
Fax
Email
shahriari@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan
City
Postal code
Phone
+98 31 3792 2950
Fax
Email
shahriari@nm.mui.ac.ir
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
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