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Comparison of ringer with ringer lactate as a prime solution in coronary artery bypass graft

Protocol summary

Study aim
Comparison of ringer with ringer lactate as a prime solution in coronary artery bypass graft
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
Intervention group1: Oxygenator content contains 1600 cc of prime solution including heparin, hydroxyethyl starch and ringer. Intervention group2: Oxygenator content contains 1600 cc of prime solution including heparin, hydroxyethyl starch and Ringer's lactate.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Patients Candidate for Coronary Artery Bypass Graft Surgery, Age 20 to 75 years ,Weight less than 50 kg and over 100 kg, Acid-disorder disturbance Exclusion Criteria:Cardiopulmonary pump duration over 6 hours, Emergency surgery, Chronic renal failure, Anemia (Hb <10 g / dl), Coagulopathy ,Pulmonary Failure ,Diabetes mellitus, Liver problem, Acid-disorder disturbance.
Intervention groups
Intervention group1: Oxygenator content contains 1600 cc of prime solution including heparin, hydroxyethyl starch and ringer. Intervention group2: Oxygenator content contains 1600 cc of prime solution including heparin, hydroxyethyl starch and Ringer's lactate.
Main outcome variables
Blood PH ,Serum bicarbonate level ,Base excess ,PaCO2 .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N94
Registration date: 2020-01-10, 1398/10/20
Registration timing: prospective

Last update: 2020-01-10, 1398/10/20
Update count: 0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ringer with ringer lactate as a prime solution in coronary artery bypass graft
Public title
Comparison of ringer with ringer lactate as a prime solution in coronary artery bypass graft
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Candidate for Coronary Artery Bypass Graft Surgery Age 20 to 75 years Weight less than 50 kg and over 100 kg
Exclusion criteria:
Cardiopulmonary pump duration over 3 hours Emergency surgery Chronic renal failure Anemia (Hb <10 g / dl) Coagulopathy Pulmonary Failure Diabetes mellitus Liver problem Acid-disorder disturbance
Age
From 20 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups of 27 using the table from www.randomization .org.
Blinding (investigator's opinion)
Double blinded
Blinding description
Primer solution is provided by a person who does not know the study groups and it is provided by a perfusionist. The patient, clinical caregiver, and outcome assessor will not be aware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Etichs Committee oF Shiraz Univesrity of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-07-24, 1398/05/02
Ethics committee reference number
IR.SUMS.MED.REC.1398.298

Health conditions studied

1

Description of health condition studied
Coronary Artery Bypass Graft Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Blood PH
Timepoint
15 minutes after the start of cardiopulmonary bypass, in the warm-up phase at 34 ° C.
Method of measurement
Arterial blood sample

2

Description
Serum bicarbonate level
Timepoint
15 minutes after the start of cardiopulmonary bypass, in the warm-up phase at 34 ° C.
Method of measurement
Arterial blood sample

Secondary outcomes

1

Description
Base excess
Timepoint
15 minutes after the start of cardiopulmonary bypass, in the warm-up phase at 34 ° C.
Method of measurement
Arterial blood sample

2

Description
PaCO2
Timepoint
15 minutes after the start of cardiopulmonary bypass, in the warm-up phase at 34 ° C.
Method of measurement
Arterial blood sample

Intervention groups

1

Description
Intervention group1: Oxygenator content contains 1600 cc of prime solution including heparin, hydroxyethyl starch and ringer.
Category
Prevention

2

Description
Intervention group2: Oxygenator content contains 1600 cc of prime solution including heparin, hydroxyethyl starch and Ringer's lactate.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Ghasem Ghasempour
Street address
Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3227 9701
Email
faghihihsp@sums.ac.ir

2

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Ghasem Ghasempour
Street address
Namazi Hospital,Namazi Square
City
Shiraz
Province
Fars
Postal code
1331171936
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ghasem Ghasempour
Position
perfusionist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
ghasemghasempoor@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahram Ghasemzadeh
Position
Cardiac surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz شیراز
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
ghasemzadeh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Its against our policies.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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