Protocol summary

Study aim
effect of ringer and lactated ringer as prime solution on acidosis and lactate level in noncyanotic pediatric cardiac surgeries
Design
50 children undergoing open heart surgery are randomly divided into two groups.This clinical trial with two parallel groups will be double blinded.
Settings and conduct
This study will be conducted in the operating room of Shahid Rajaee Heart Center and patients and the surgical team will be unaware of the type of solution used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Children with non-cyanotropic heart disease, Having consent from the parents of the patient, Non-emergency surgery, Absence of coagulation disorders. Absence of anemia (hemoglobin less than 10 g / dl), Absence of hepatic impairment, Absence of kidney failure, Absence of lung failure, Absence of diabetes, Absence of acid disorder and severe preoperative hypertension, Lactate levels greater than 2 mM per liter before surgery, Not having a history of heart surgery (redo) Exclusion criteria:Periods of arterial blood pressure reduction before surgery, Ultrafiltration during bypass
Intervention groups
Intervention group, lactated ringer 350 to 400 cc, once at onset bypass. Control group, Ringer's solution 350 to 400 cc, once at onset bypass.
Main outcome variables
The variables of pH, Bicarbonate, Base Excess, Chloride, Lactate and the amount of sodium bicarbonate injected will be recorded.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180407039222N1
Registration date: 2018-07-08, 1397/04/17
Registration timing: registered_while_recruiting

Last update: 2018-07-08, 1397/04/17
Update count: 0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Davood Samiei
Name of organization / entity
Shaheed Rajaei Cardiovascular Medical and Research Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2454
Email address
samieidavood@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of ringer's solution and lactated ringer as prime solution on acidosis and lactate level in noncyanotic pediatric cardiac surgery
Public title
Comparison of Ringer and Ringer Lactate Solution on Acidose and Lactate Status in Pediatric Heart Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children with non-cyanotropic heart disease Having consent from the parents of the patient Non-emergency surgery Absence of coagulation disorders Absence of anemia (hemoglobin less than 10 g / dl) Absence of hepatic impairment Absence of kidney failure Absence of lung failure Absence of diabetes Absence of acid disorder and severe preoperative hypertension Lactate levels greater than 2 mM per liter before surgery Not having a history of heart surgery (redo) Age 12 to 48 months
Exclusion criteria:
Periods of arterial blood pressure reduction before surgery Ultrafiltration during bypass
Age
From 12 months old to 48 months old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, lottery through sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participating patients,Responsible perfusionist and Responsible for data collection were kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic comittee of Shahid Rajai Cardiovascular Medical and Research Center
Street address
Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center
City
Tehran
Province
Tehran
Postal code
19956114331
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
RHC.AC.IR.REC.1395.42

Health conditions studied

1

Description of health condition studied
Metabolic Acidosis
ICD-10 code
E87.2
ICD-10 code description
Acidosis

Primary outcomes

1

Description
pH level
Timepoint
Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass.
Method of measurement
Arterial blood sample and arterial gas analyzer

2

Description
Blood lactate level
Timepoint
Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass.
Method of measurement
Arterial blood samples and Care diagnostica machine

3

Description
Arterial blood bicarbonate level
Timepoint
Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass.
Method of measurement
Arterial blood sample and arterial gas analyzer

4

Description
Arterial base excess level
Timepoint
Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass.
Method of measurement
Arterial blood sample and arterial gas analyzer

5

Description
Arterial blood chloride level
Timepoint
Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass.
Method of measurement
Arterial blood sample and arterial gas analyzer

Secondary outcomes

1

Description
The amount of sodium bicarbonate injected to correct acidosis
Timepoint
5 minutes, 30 minutes and one hour after the start of the bypass
Method of measurement
observation

Intervention groups

1

Description
Intervention group: In the first group, a lactate ringer solution will be used to prepare the cardiopulmonary bypass system.Also, the venofundin 6% etherified starch solution at 15 cc / kg body weight, heparin 3 units per ml of prime solution, sodium bicarbonate at 24 mEq / l of prime solution and Mannitol 0.5 grams per kilogram of body weight will be added.In the case of low hematocrit, packed cell will also be used.The amount of lactated ringer solution will be about 350-400 cc and once at the start of the bypass.The Ringer Lactate solution is the product of Shahid Ghazi Tabriz factory and made in Iran.
Category
Treatment - Drugs

2

Description
Control group: In the second group, a ringer solution will be used to prepare the cardiopulmonary bypass system.Also, the venofundin 6% etherified starch solution at 15 cc / kg body weight, heparin 3 units per ml of prime solution, sodium bicarbonate at 24 mEq / l of prime solution and Mannitol 0.5 grams per kilogram of body weight will be added.In the case of low hematocrit, packed cell will also be used.The amount of Ringer's solution will be about 350-400 cc and once at the start of the bypass.Ringer's solution is the product of Iranian Pharmaceutical & Parenteral Products factory and made in Iran.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating room of Shahid Rajaee Cardiovascular Center Tehran
Full name of responsible person
Davood Samiei
Street address
Ayatollah Hashemi Rafsanjani Highway. cross Vali-Asr Ave.
City
Tehran
Province
Tehran
Postal code
19956114331
Phone
+98 21 2392
Email
samdvd1979@yahoo.com
Web page address
http://rhc.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Rajaee Cardiovascular Center Tehran
Full name of responsible person
دکتر مازیار غلامپور
Street address
Highway Ayatollah Hashemi Rafsanjani Exp,cross Valiasr St
City
Tehran
Province
Tehran
Postal code
19956114331
Phone
+98 21 2392
Email
drgholampour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaee Cardiovascular Center Tehran
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
Shahid Rajaee Cardiovascular Center
Full name of responsible person
Davood Samiei
Position
Perfusionist
Latest degree
Master
Other areas of specialty/work
Perfusionit
Street address
Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center
City
Tehran
Province
Tehran
Postal code
19956114331
Phone
+98 21 2392 2454
Email
samdvd1979@yahoo.com
Web page address
http://rhc.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Rajai Cardiovascular Center
Full name of responsible person
Davood Samiei
Position
Perfusionist
Latest degree
Master
Other areas of specialty/work
Perfusion
Street address
Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center
City
Tehran
Province
Tehran
Postal code
19956114331
Phone
+98 21 2392 2454
Email
samdvd1979@yahoo.com
Web page address
http://rhc.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Rajai Heart Center
Full name of responsible person
Davood Samiei
Position
Perfusionist
Latest degree
Master
Other areas of specialty/work
Perfusion
Street address
Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center
City
Tehran
Province
Tehran
Postal code
19956114331
Phone
+98 21 2392 2454
Email
samieidavood@rhc.ac.ir
Web page address
http://rhc.ac.ir/

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
Patient privacy
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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