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Comparison between 4 existing tube feeding formulas in incidence & severity of diarrhea in intensive care unit (ICU) patients .

Protocol summary

Summary
Type of formula is a cause of diarrhea in enterally tube fed patients in ICU. Formulas have been used for enteral fed patients in general & central ICU in Namazi hospital, unfortunately diarrhea have been a major problem with enteral feeding in both ICU due to this main cause increase in hospital cost and length of stay in the ICU. Now there are 4 types available of formulas(fresubin Original ,ensure powder, entera meal high fiber, entera meal standard) , so we`re going to compare these formulas regarding to incidence & severity of diarrhea. Objectives: 1- the determination of incidence & severity of diarrhea in patients who are fed by Fresubine Original formula. 2- the determination of incidence & severity of diarrhea in patients who are fed by Entera Meal Standard formula. 3- the determination of incidence & severity of diarrhea in patients who are fed by Entera Meal High Fiber formula. 4- the determination of incidence & severity of diarrhea in patients who are fed by Ensure Powder formula. 5- Comparison incidence & severity of diarrhea between 4 formulas. methode:it`s a clinical trail study. 128 patients who are admitted in Central & General ICU of Namazi hospital and they don`t have renal/liver failure or diabetice , immunocompromised, gasteric surgy , drug abuse and they feed by gastric will participated in this study. Data will collected from initiating Ng feeding in ICU patients to maximum 7 days .in advance patient will entered in groups of formula by Block Randomize method. We will use Harris Benedict method to measure energy expenditure and according to Namazi ICU protocol for advancing patient diet and GRV( Gastric Residual Volume) , the amount of formula will increase until achieve goal calorie. For this study, diarrhea was defined as the‘abnormal passage of loose or liquid stools more than three times daily and/or a volume of stool greater than 200 g/day during the patient’s ICU admission’ . No validated diarrhea measurement tool are used in the ICU at this study. Faecal output was record subjectively by nursing staff. Stool consistency was recorded as formed, semi-formed, loose or watery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112121566N4
Registration date: 2012-01-08, 1390/10/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Farid Zand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4270
Email address
zandf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
DarmanYab Darou Co. and Jahan Behbood Co.
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-08-20, 1391/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between 4 existing tube feeding formulas in incidence & severity of diarrhea in intensive care unit (ICU) patients .
Public title
Comparison between 4 existing tube feeding formulas in incidence & severity of diarrhea in intensive care unit (ICU) patients .
Purpose
Prevention
Inclusion/Exclusion criteria
Patients are eligible for inclusion if they: (1) are Nasogastric tube fed via Bolus infusion; (2) ≥18 years of age; and (3)are expected to have an ICU length of stay (LOS) >7days. Participants are excluded from the study if (1) they need special formulas such as diabetic formula , hepatic formula; (2) patients who are immunocompromised, suffered renal /hepatic failure, gasteric surgy and post-operative patients; (3) Gastrastomy / Jejunostomy patients ;(4) parenteral nutrition patients ; (5) drug abuse patients; ( 6) change of feeding to special formula during study and (7) patients who are expected to die < 7 days.
Age
To 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 128
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
Shiraz University of Medical Science
Street address
Namazi Haspital
City
Shiraz
Postal code
Approval date
2011-12-29, 1390/10/08
Ethics committee reference number
CT-90-3709

Health conditions studied

1

Description of health condition studied
Diarrhoea in patients admitted in Intensive Care Unit
ICD-10 code
K59.1
ICD-10 code description
Functional diarrhoea

Primary outcomes

1

Description
Diarrhea Incidence
Timepoint
A week
Method of measurement
Diarrhoea was defined as the ‘abnormal passage of loose or liquid stools more than three times daily and/or a volume of stool greater than 200 g/day during the patient’s ICU admission’No validated diarrhea measurement tool are used in the ICU at this study. Faecal output was record subjectively by nursing staff. Stool consistency was recorded as formed, semi-formed, loose or watery

Secondary outcomes

1

Description
Percent of calorie intake in first day
Timepoint
One day
Method of measurement
The amount of intake calorie in first day divide total caloric requested for patient multiple 100

2

Description
GI intolerance
Timepoint
Daily for seven days
Method of measurement
Report GRV>250cc every day during 7 days

3

Description
Percent of calorie intake in third day
Timepoint
One day
Method of measurement
The amount of intake calorie in third day divide total caloric requested for patient multiple 100

4

Description
Percent of calorie intake in fourth day
Timepoint
One day
Method of measurement
The amount of intake calorie in fourth day divide total caloric requested for patient multiple 100

5

Description
Precent of caloric intake in second day
Timepoint
One day
Method of measurement
The amount of intake calorie in second day divide total caloric requested for patient multiple 100

6

Description
Precent of caloric intake in fifth day
Timepoint
One day
Method of measurement
The amount of intake calorie in fifth day divide total caloric requested for patient multiple 100

7

Description
Precent of caloric intake in sixth day
Timepoint
One day
Method of measurement
The amount of intake calorie in sixth day divide total caloric requested for patient multiple 100

8

Description
Precent of caloric intake in seventh day
Timepoint
A day
Method of measurement
The amount of intake calorie in seventh day divide total caloric requested for patient multiple 100

9

Description
Nausea& vomiting
Timepoint
Daily for seven days
Method of measurement
Nursing report every days until 7 days

Intervention groups

1

Description
Prescribing Fresubine Original formula as first intervention
Category
Treatment - Other

2

Description
Prescribing "Ensure Powder" formula as secend interavention
Category
Treatment - Other

3

Description
Prescribing " Entera Meal Standard" formula as third intervention
Category
Treatment - Other

4

Description
Prescribing " Entera Meal High Fiber" formula as fourth intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr. Zand
Street address
Namazi Haspital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
DarmanYab Darou
Full name of responsible person
Dr. Javaheri
Street address
No.32, Soraya Bldg, No. 10, Pardis ST, Mollasadra Ave , Vanak Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DarmanYab Darou
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Jahan Behbood
Full name of responsible person
Asana Eshghi
Street address
no. 22, Nezam Alley, Shahnazar St , Mohseni Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahan Behbood
Proportion provided by this source
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
Shiraz University of Medical Science
Full name of responsible person
Fahimeh Edrissi
Position
Nutritionist
Other areas of specialty/work
Street address
#19, no. 46, Alley No. 2/2, Chamran Ave.
City
Shiraz
Postal code
Phone
+98 71 1646 2503
Fax
Email
fahimehed@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Farid Zand
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesia
City
Shiraz
Postal code
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
zandf@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Fahimeh Edrissi
Position
Nutritionist
Other areas of specialty/work
Street address
Unit 19, No. 46, Alley No. 2/2, Chamran Ave.
City
Shiraz
Postal code
Phone
+98 71 1646 2503
Fax
Email
fahimehed@yahoo.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
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