Comparison the efficiency of nutrition with entera meal standard formula and Ensure and standard gavage of hospital in traumatic patients at ICU in Vali-Asr hospital, Arak.
Comparison the efficiency, complications and price of nutrition with entera meal standard formula and Ensure and standard gavage of hospital in traumatic patients at ICU in Vali-Asr hospital, Arak and
Design
A randomized, double blinded clinical trial with two intervention and one control group, three parallel group and outcome assessment
Settings and conduct
This trial will be performed at ICU in Arak Vali-asr hospital. 66 traumatic patients will be divided in three groups and each group has one of three formulas(Ensure_entera meal_hospital gavage). trial is double blinded and researcher and data analyser don't know the formula of each patient
Participants/Inclusion and exclusion criteria
.Inclusion criteria:
Age 18 to 50
Need to Nutrition with NG tube or Gastrostomy or Jejunostomy
Multiple trauma
.Exclusion criteria:
Death
Gavage intolerance for more than 24 hours
Patient re-NPO for more than 24 hours
Reaction to Folate
History of DM, hyper or hypothyroidism and metabolic disease
Sensitivity to milk protein
Gastro-intestinal fistula
Burning
Renal failure
Hepatic failure
Intervention groups
.First intervention group: Entera meal standard formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient
. Second Intervention group: Ensure formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient
. Control group: Standard gavage of hospital _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient
Main outcome variables
.Serum total protein level
. Mid arm circumflex
. Serum electrolytes: (Na, K, Ca, Mg)
. NUTRIC score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180112038319N1
Registration date:2018-10-27, 1397/08/05
Registration timing:registered_while_recruiting
Last update:2018-10-27, 1397/08/05
Update count:0
Registration date
2018-10-27, 1397/08/05
Registrant information
Name
Shima Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3221 8317
Email address
sh.shahri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficiency of nutrition with entera meal standard formula and Ensure and standard gavage of hospital in traumatic patients at ICU in Vali-Asr hospital, Arak.
Public title
Comparison the efficiency of nutrition with entera meal and Ensure and standard gavage of hospital in traumatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50
Need to Nutrition with NG tube or Gastrostomy or Jejunostomy
Multiple trauma
Exclusion criteria:
Death
Gavage intolerance for more than 24 hours
Patient re-NPO for more than 24 hours
Reaction to Folate
History of DM, hyper or hypothyroidism and metabolic disease
Sensitivity to milk protein
Gastro-intestinal fistula
Burning
Renal failure
Hepatic failure
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization technique: Simple randomization with randomization table.
Patients with similar situation will be chosen. Each patient has a number. The numbers are in randomization table and 66 numbers will be chosen randomly. All the patients have equal chances. Unit of Randomization is person. Researcher and data analyser know the number of patients but they don't know the formula of each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
This clinical trial will be performed in double blind way That means researcher,data analyser,nurses, hospital personnel and the patient don't know the formula. The formula will be prepared and coded in clean room and will be given to the researcher who gives them to the patients. The preparator knows the formula and others don't know. Data Monitoring Commmittee possess all patient's data
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences,basij Sq
City
Arak
Province
Markazi
Postal code
1884
Approval date
2017-12-02, 1396/09/11
Ethics committee reference number
IR.ARAKMU.REC.1396.201
Health conditions studied
1
Description of health condition studied
traumatic patients
ICD-10 code
T79.9
ICD-10 code description
Unspecified early complication of trauma
Primary outcomes
1
Description
Serum total protein level: Serum albumin and globulin measurement
Timepoint
Serum total protein measurement at the beginning of trial(first day) and 8 and 14 days after Formula beginning.
Method of measurement
Blood test
2
Description
Mid arm circumflex
Timepoint
Mid arm circumflex measurement at the beginning of trial(first day) and 8 and 14 days after Formula beginning.
Method of measurement
non-stretchable tape measure
3
Description
Serum electrolytes: (Na, K, Ca, Mg)
Timepoint
Serum electrolytes measurement at the beginning of trial(first day) and 8 and 14 days after Formula beginning.
Method of measurement
Blood serum test
4
Description
NUTRIC score: This factor is designed to quantify the risk of critically ill patients developing adverse events at ICU. It determined with the table(age_APACHE score_SOFA score_ number of co-morbidities_days from hospital to ICU admission).
Timepoint
NUTRIC score determination at the beginning of trial(first day) and 8 and 14 days after Formula beginning.
Method of measurement
NUTRIC score table
Secondary outcomes
1
Description
Side effect: diarrhea/Vomiting/Sensitivity
Timepoint
Complication incidence at the beginning of trial(first day) and 8 and 14 days after Formula beginning.
Method of measurement
Patient physical examination
2
Description
Final price of each formula
Timepoint
end of fourteenth day.
Method of measurement
Calculation the price of formula
Intervention groups
1
Description
First intervention group: Entera meal standard formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient
Category
Treatment - Other
2
Description
Second Intervention group: Ensure formula _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient
Category
Treatment - Other
3
Description
Control group: Standard gavage of hospital _ Dose and number of times is due to nutritional need of each patient. Duration of use is 14 days for each patient
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Vali-Asr hospital., Shahid Shirodi street., Arak
City
Arak
Province
Markazi
Postal code
38149-5-7558
Phone
+98 86 3222 2003
Fax
+98 86 2231 2830
Email
b.mahmudie@arakmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3645
Fax
+98 86 3222 2003
Email
m.arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?