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The effect of personalized parenteral nutrition on Intensive care unit (ICU) patients

Protocol summary

Study aim
Determination of the effect of personalized parenteral nutrition on ICU patients
Design
Randomized clinical trial,2-blind trial,60 ICU patients candidate for parenteral nutrition, Intervention and control groups through randomization,30 patients as intervention group & 30 patients as control group.
Settings and conduct
We attend at ICU of Razi hospital in Rasht and complete consent form, information will be required using questionnaires: Medical history, Anthropometric measurement, Dietary intake, Biochemical indices (at baseline and after 14 days). This is a Double-blind trial study, which intervention and control groups are blinded to intervention assignment and nurses who assess and collect data on outcome, are blinded to groups' assignment.
Participants/Inclusion and exclusion criteria
Study will be done in the Rasht Razi hospital.60 ICU patients who are candidate for parenteral nutrition,will be selected and enter to the study in the intervention and control groups through simple randomized selection.Inclusion criteria:Informed consent,need to parenteral nutrition at least 24-h of hospitalization and exclusion criteria:no tendency,no parenteral nutrition indication for more than 1 week,death,not having severe or middle malnutrition.
Intervention groups
We avoid feeding the lipid to intervention group in the first of hospitalization. Required protein will be calculated upon patient's status and determined by required percent of amino acids & Dextrose. We use daily relevant vials for providing vitamins & minerals. Control group daily receive low calorie of intra venous diet(800-1000 calories) upon hospital's routine. We usually administer Dextrose every day, providing 70% and administer Aminoven or Intralipid every other day, providing 30% of patient's calorie.All of measurements repeated after one week.
Main outcome variables
Urea, Creatinine, CRP, ICU hospitalization, Survival rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151226025699N4
Registration date: 2020-06-03, 1399/03/14
Registration timing: prospective

Last update: 2020-06-03, 1399/03/14
Update count: 0
Registration date
2020-06-03, 1399/03/14
Registrant information
Name
Saeid Doaei
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 6744
Email address
sdoaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of personalized parenteral nutrition on Intensive care unit (ICU) patients
Public title
The effect of parenteral nutrition on ICU patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participation Need to parenteral nutrition At least 24-h of hospitalization
Exclusion criteria:
Having no indication for parenteral nutrition for more than 1 week Unstable hemodynamic conditions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients of ICU are assigned to the intervention and control groups through simple individualized randomization by online software (randomizer.org).
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects (both the case and control groups) are blinded to intervention assignment. Also, nurses who assess and collect data on outcome, are blinded to groups' assignment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Cancer research center of Shahid beheshti University of Medical Sciences
Street address
Tehran, Tajrish square, Tajrish martys hospital,Cancer research center
City
Tajrish
Province
Tehran
Postal code
1985717413
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.SBMU.CRC.REC.1398.015

Health conditions studied

1

Description of health condition studied
Gastrointestinal hemorrhage
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal hemorrhage, unspecified

Primary outcomes

1

Description
Urea
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

2

Description
Creatinine
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

3

Description
C reactive protein (CRP)
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

4

Description
Serum albumin
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

Secondary outcomes

1

Description
ICU hospitalization
Timepoint
Baseline, 14-day after intervention
Method of measurement
Patients documents

2

Description
Survival rate
Timepoint
During 14-day intervention
Method of measurement
Patients documents

3

Description
Weight
Timepoint
During 14-day intervention
Method of measurement
This anthropometric indicator will be gathered from the patients records.

4

Description
Body mass index (BMI)
Timepoint
During 14-day intervention
Method of measurement
This anthropometric indicator will be gathered from the patients records.

5

Description
Malnutrition status
Timepoint
During 14-day intervention
Method of measurement
It will be evaluated by weight & BMI criteria and by the level of serum albumin. We also use the Nutritional Risk Screening (NRS 2002) criterion for more evaluation.

Intervention groups

1

Description
After the gain of real weight and evaluation of disease status and chemistry results, the amount of required calorie will be estimated according to the ASPEN guidelines and then, the appropriate diet will be designed. We avoid to feeding the lipid in the first of hospitalization. The required protein will be calculated according to the patient's status and determined by the required percent of amino acids and Dextrose. We also will use the daily relevant vials for providing the vitamins and required minerals. Finally, we will insert the diet with relevant advises in to the conference form and deliver to the relevant specialist doctor for final acceptance.
Category
Treatment - Drugs

2

Description
Control group will daily receive low calorie of parenteral diet, including 800 to 1000 calories according to the hospital's routine. We usually administer Dextrose every day, which provide 70% of patient's calorie and administer Aminoven or Intralipid every other day, which provide 30% of patient's calorie. All of measurements repeated after one week.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Siamak Rimaz
Street address
RaziSardare Jangal Boulevard
City
Tehran
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Email
sdoaee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pr. Mohammad Esmaeil Akbari
Street address
Chamran Highway Yeman street-Arabi street
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Arsalan salari
Street address
Parastar Street
City
Rasht
Province
Guilan
Postal code
41887-94755
Phone
+98 13 3334 6489
Email
salari@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rasht university of medical sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pr. Mohammad Esmaeil Akbari
Position
Super-specialist of Endocrine and Cancer surgery
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Tehran, Tajrish square, Tajrish martys hospital,Cancer research center
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
021 22748001-2
Email
me-akbari@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Saeid Doaei
Position
Tehran shahid beheshti university of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sardare Jangal Boulevard
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Email
sdoaei@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Saeid Doaei
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Beheshti University of Medical Sciences, Tehran, IRAN.
City
Tehran
Province
Tehran
Postal code
009821
Phone
+98 21 6643 6744
Email
sdoaei@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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