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Studing the effect of remote ischemic preconditioning on blood Troponin I level in patients undergoing open cardiosurgery

Protocol summary

Summary
The aim of this study is to identify the effect of remote ischemic preconditioning on troponin I.The individuals will be randomized using sealed envelopem and the study will be double blind and unicentral clinical trial. IFor the purpose of this study 28 patients will be chosen and will be divided to two equal groups(14 case and 14 control). Including criteria: ASA 2 or 3, normal troponin I level, no recent myocardial infarction, ejection fraction more than 35%, no renal and hepatic dysfunction, no arterio-venous fistula, no lymph edema. Excluding criteria: ASA 4 or more, elevated baseline troponin I, myocardial infarction in recent 4 weeks, ejection fraction less than 35%, renal dysfunction, arterio venous fistula, lymph edema, severe endocrine or hepatic dysfunction. At first, two mililiter of patient's arterial blood will be send to laboratory for measurement of baseline troponin I. In case group after induction of anesthesia and intubation, pneumatic torniquet will inflate for 5 minutes up to 200 mmHg on the upper arm and deflate for 5 minutes.This cycle will be repeated two times.Second and third samples will be send to labaratory at 6,24 hour after the first sample.After remote ischemic preconditioning troponin I level, intubation time,inotrop requirement and patient hemodynamic during and after surgery will be evaluated.In control group after induction of anesthesia and intubation pneumatic torniquet will be set on the right upper limb but will not be inflated and blood samples will be send to laboratory like case group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016120431226N1
Registration date: 2017-01-18, 1395/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Mohsen Moaddeli
Name of organization / entity
Ahwaz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61336754360
Email address
moaddeli.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
No financial source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studing the effect of remote ischemic preconditioning on blood Troponin I level in patients undergoing open cardiosurgery
Public title
Effect of ischemia in cardio surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: ASA 2,3; normal troponin one level; no recent myocardial infarction; ejection fraction more than 35%; no renal and hepatic dysfunction; no arterio-venous fistula; no lymph edema. Excluding criteria: ASA 4 or more; elevated baseline troponin I; myocardial infarction in recent 4 weeks; ejection fraction less than 35%; renal dysfunction; arterio-venous fistula; lymph edema; severe endocrine or hepatic dysfunction.
Age
From 19 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Science
Street address
Golestan Blv, Ahwaz University of Medical Science
City
Ahwaz
Postal code
61357-15794
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.AJUMS.REC.1395.501

Health conditions studied

1

Description of health condition studied
coronary disease/valvular disease
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Troponin I
Timepoint
time0, 6 and 24 hour after intervention
Method of measurement
quantitative troponin kit

Secondary outcomes

1

Description
intubation time
Timepoint
6 hour, 24 hour
Method of measurement
clock

2

Description
systolic and diastolic pressure
Timepoint
time 0,time 6,time 24
Method of measurement
Sphygmomanometer

Intervention groups

1

Description
Intervention group: after induction of anesthesia and intubating the patient under open cardiac surgery, pneumatic cuff will be fastened on patient’s arm and will be inflated up to 200 mmHg and kept in this condition for 5 minutes and then deflated and the arm will rest for 5 minutes .This procedure will be repeated two times more.
Category
Treatment - Other

2

Description
Control group: The pneumatic torniquet cuff will only be fastened and will not be inflated.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiosurgery ward of Golestan hospital
Full name of responsible person
Mohsen Moaddeli
Street address
Golestan hospital, Farvardin st, Golestan blv
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Ahwaz University of Medical Science
Full name of responsible person
Mohsen Moaddeli
Street address
Vice Chancellor for research of Ahwaz University of Medical Science
City
Ahwaz
Grant name
-
Grant code / Reference number
- -
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ahwaz University of Medical Science
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
Ahwaz University of Medical Science
Full name of responsible person
Mohsen Moaddeli
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Golestan hospital, Farvadin St, Golestan Blv
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 3336 7543
Fax
+98 61 3336 7543
Email
moaddeli.m@ajums.ac.ir; moadelimohsen@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz University of Medical Science
Full name of responsible person
Mohsen Moaddeli
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Golestan hospital, Farvardin St, Golestan Blv
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 3336 7543
Fax
+98 61 3336 7543
Email
moaddeli.m@ajums.ac.ir; moadelimohsen@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz University of Medical Science
Full name of responsible person
Mohsen Moaddeli
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Golestan hospital, Farvardin St, Golestan Blv
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 3336 7543
Fax
+98 61 3336 7543
Email
moaddeli.m@ajums.ac.ir; moadelimohsen@yahoo.com
Web page address
www.ajums.ac.ir

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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