The aim of this study is to investigate the effect of oral magnesium supplementation on patient outcomes after cardiac surgery.In this clinical trial100 patients undergoing open heart surgery who have eligibility criteria will be randomly assigned to the control and experimental groups.One day before surgery, patients who were hospitalized in the internal wards of men or women were given sufficient explanation. informed written consent will be obtained from their. In this day the first part of the questionnaire which contain personal information and medical history, will be completed by the researcher personally. The Magnesium levels in both groups of patients Preoperative and also on the third day after that shall be measured. Patients in the intervention group will receive 500 mg of oral magnesium supplement every day from one day before the surgery and then will be continued until hospital discharge. After the surgery study outcomes including atrial fibrillation, Hypomagnesemia, nausea and vomiting, constipation, and hyperglycemia are measured by the researcher.the study results will be analyzed by SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402026778N4
Registration date:2014-04-29, 1393/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-29, 1393/02/09
Registrant information
Name
Seyed Tayeb Moradian Vafaei
Name of organization / entity
School of nursing and midwifery, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 4258
Email address
t-moradian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
nursing faculty, Baghyattallah university of medical sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect oral magnesium supplementation on outcomes improvement of patients after open heart surgery
Public title
Effect of oral magnesium supplementation on outcomes after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with non-emergency cardiac surgery; age greater than 30 and less than 70 years; Not suffering from preoperative atrial fibrillation; Not suffering from Preoperative nausea - vomiting and constipation; Not suffering from renal failure; No history of stroke and transient ischemic attack in the past month.
Exclusion Criteria: Re operation for bleeding control; Being pacemaker dependent Postoperatively; The incidence of renal failure during the study
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Baqiyatallah University of Medical Science
Street address
Tehran Vanak Square, Molla Sadra Ave.
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
Meeting No. 34
Health conditions studied
1
Description of health condition studied
Disorders of magnesium metabolism
ICD-10 code
E83.4
ICD-10 code description
hypomagnesemia
Primary outcomes
1
Description
Hypomagnesaemia
Timepoint
Preoperative and postoperative third day
Method of measurement
Serum ionized magnesium
2
Description
postoperative Nausea and vomiting
Timepoint
5 days, the patient's admission to the intensive care unit after cardiac surgery and internal parts of the heart
Method of measurement
Morrow assessment of nausea and vomiting
3
Description
Hyperglycemia
Timepoint
5 days, the patient's admission to the intensive care unit after cardiac surgery and internal parts of the heart
Method of measurement
Measurement of blood glucose
4
Description
Constipation
Timepoint
POST SURGERY 10 days
Method of measurement
According to Rome (III),Defecation of patients is recorded.
Secondary outcomes
1
Description
Post Operation Artrial Fibrilation
Timepoint
from the first to 5th postoperation day
Method of measurement
electrocardiogram and intensive care and internal wards central monitoring
Intervention groups
1
Description
The experimental group receiving500 mg of oral magnesium supplementation per day.
Category
Treatment - Drugs
2
Description
Patients in the control group will receive the hospital routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart Hospital jamaran
Full name of responsible person
Dr. Mohammad Saeid Ghiasi
Street address
Jamaran Heart Hospital, Jamran St, Niavaran St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nursing faculty, Baqiyyatallah university of medical sciences
Full name of responsible person
Doctor Abbas Ebad
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaei St, Vanak Square, Tehran ... (Aj)
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing faculty, Baqiyyatallah 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
Baqiyyatallah university of medical sciences
Full name of responsible person
Alireza Mohamadpour
Position
Master of scince in nursing student
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran
City
Tehran
Postal code
Phone
+98 912 378 1448
Fax
Email
bahar_shahab@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Faculty , Baqiyyatallah university of medical sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
Faculty Member
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran
City
Tehran
Postal code
Phone
+98 21 2228 6057
Fax
Email
t-moradian@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)