Evaluation of oral administration of glutamine to improve cardiovascular function in patients undergoing open heart surgery and to evaluate the effect of this combination on surgical outcomes.
Design
The randomized clinical trial with the intervention and control group, parallel groups, double blinded
Settings and conduct
A randomized clinical trial that is performed on patients undergoing non-emergency open heart surgery who are referred to Fatemeh Zahra Hospital in Sari. The population studied in this study includes all adult patients (aged 18-80) including men and women who have inclusion criteria for research. Patients and therapists are not aware of the type of drug contained in powders (glutamine, Avicel and starch), and only the researcher knows the code based on the code (code A or code B)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Patients who are candidates for open heart surgery, Sinus rhythm in the patient before surgery
Exclusion criteria: Age over 80 years, History of chronic lung, liver, kidney and thyroid diseases and heart failure, Total Bilirubin more than 10 mg / dL, Creatinine clearance less than 30 ml / min
Intervention groups
A total of 106 patients with open heart surgery candidates were randomly divided into two groups of 53. For the first group, 0.5 g / kg of glutamine is taken orally once a day, and for the control group, placebo (Avicel and starch powder) is added. The drug forms of placebo are prepared in terms of the appearance of glutamine.
Main outcome variables
Duration of admission to ICU, Duration of hospitalization, Mortality after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151109024975N10
Registration date:2018-08-29, 1397/06/07
Registration timing:registered_while_recruiting
Last update:2018-08-29, 1397/06/07
Update count:1
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Gohar Eslami
Name of organization / entity
Mazandaran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3695
Email address
g.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Oral Glutamine Administration on Reduction of Myocardial Dmage After Open Heart Surgery, a Prospective Randomized Clinical Trial Study
Public title
Effect of Glutamine on Reducing Myocardial Damage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Candidate for open heart surgery
Preoperative sinus rhythm
Normal function of liver, renal system, pulmonary system and thyroid
Exclusion criteria:
Emergency patients
Serious water and electrolyte disorders
Unwillingness to co-operate with the patient
History of chronic lung, liver, kidney and thyroid diseases and heart failure
Age over 80 years
Pregnant and lactating women
Patients who are hypersensitive to glutamine or who are banned in any way by their administration of glutamine
Total Bilirubin more than 10 mg / dL
Creatinine clearance less than 30 ml / min
Absolute Absence of Intestinal Feeding
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Random method and description of each method: simple randomization
After determining the size of the sample, 106 people, 53 in the control group and 53 in the intervention group were considered. By co-ordinating medical records, this number was considered average for the duration of the appointment, and then the list of individuals was determined. The list was prepared based on the patients' turn-by-turn and then, using the random numbers table, the numbers of the control and intervention group were determined and compared to the coordination for the next steps.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the informed consent form, patients are told that they may receive glutamine or placebo (Avicel powder and starch). Therefore, patients are not aware of their treatment group. Since patients and therapists are not aware of the type of drug contained in powders (glutamine, Avicel and starch), only the researcher is aware of the powder on the package code (code A or code B).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of Mazandaran University of Medical Sciences
Street address
Artesh Blvd., Fatemeh-zahra hospital Mazandaran University of Medical Scienses
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.mazums.REC.1396.3093
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.0
ICD-10 code description
Acute coronary thrombosis not resulting in myocardial infarction
Primary outcomes
1
Description
Myocardial injury after open heart surgery
Timepoint
The day before the surgery (before the intervention) and the first and second days after surgery
Method of measurement
SOFA score
Secondary outcomes
1
Description
Duration of admission to ICU
Timepoint
Duration of admission
Method of measurement
Patients follow up
2
Description
Duration of hospitalization
Timepoint
Duration of admission
Method of measurement
Patients follow up
3
Description
Mortality
Timepoint
Duration of admission
Method of measurement
Patients follow up
Intervention groups
1
Description
Intervention group: A dose of 0.5 g / kg of glutamine powder is administered orally once a day during the ICU for patients.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group received placebo (Avicel powder and starch). The frequency and duration of use of placebo in the control group were similar to oral administration of glutamine powder in the intervention group (once a day and up to the time of discharge from the ICU). Patients undergoing coronary artery bypass grafting, the drug is fed through the nasopharyngeal tube. The placebo is structurally similar to glutamate powder.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh-zahra hospital Mazandaran University of Medical Scienses
Full name of responsible person
Gohar Eslami
Street address
Artesh Blvd., Center of the heart of Mazandaran
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3331 4086
Fax
+98 11 3332 4002
Email
g.eslami@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Moalem Square, Research Deputy of MazandaranUniversity of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
g.eslami@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
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
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3354 3695
Email
g.eslami@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3335 2725
Email
g.eslami@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mazandaran University of Medical Sciences, Imam Square, Three Way Joybar, Beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3695
Fax
+98 11 3335 2725
Email
g.eslami@mazums.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