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Comparative study of the effect of pulsatile flow vresus non-pulsatile flow on the antioxidant markers pre cardiopulmonary bypass in patients undergoing complex cardiac surgery

Protocol summary

Study aim
The effect of pulsatile and non-pulsatile flow on antioxidant markers during cardiopulmonary bypass in patients undergoing complex cardiac surgery will be investigated.
Design
The study has a control and intervention group, with parallel groups, blinded, randomized, phase 3 on 44 patients, and Excel software has been used for verification.
Settings and conduct
The study will be conducted in the operating room of the RHC. Patients are randomly divided into 2 groups: Group A:60 pulses per minute, Group B receives non-pulsatile flow. Blinding will be done unilaterally in such a way that the patients will be given explanations about the study, but the laboratory personnel And the sample collecting nurse will not know about the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent of the patient, Age range from 18 to 75 years, Elective patients who are candidates for complex surgery under CPB, Patients with 30% ≥ Ejection fraction, Not having a history of heart surgery, Not having liver failure in the form of ALT>40 units/L and AST>140 units/L, Not having impaired pulmonary function test before surgery in the form of forced expiratory volume in first second >65%, Not having creatinine level higher than 2 mg/dl, Not having hemoglobin level lower than 10 mg/dl, Not having active inflammation in the last month, Not having a history of taking antioxidant and anti-inflammatory drugs in the last month. Exclusion criteria: Aortic cross-clamp time less than 20 minutes, Pulse pressure less than 20 mmHg (in pulsating groups), Redo surgeries, Emergency surgeries
Intervention groups
The intervention group includes patients who will use pulsating flow with the same settings.The control group is the group in which patients will receive non-pulsatile flow.
Main outcome variables
Checking the level of MDA and TAC, the level of lactate, the level of liver enzymes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240316061314N1
Registration date: 2024-07-26, 1403/05/05
Registration timing: registered_while_recruiting

Last update: 2024-07-26, 1403/05/05
Update count: 0
Registration date
2024-07-26, 1403/05/05
Registrant information
Name
Arezoo Moradi
Name of organization / entity
Shahid rajaee heart center
Country
Iran (Islamic Republic of)
Phone
+98 21 23921
Email address
arezoo.m07@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of pulsatile flow vresus non-pulsatile flow on the antioxidant markers pre cardiopulmonary bypass in patients undergoing complex cardiac surgery
Public title
Comparative study of the effect of pulsatile flow vresus non pulsatile flow on the antioxidant markers pre cardiopulmonary bypass in patients undergoing complex cardiac surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients conscious satisfaction Age range of 18 to 75 Patients undergoing elective complex surgery on CPB Patients with 30% ≥ Ejection fraction Having no history of heart surgery Having no liver dysfunction AST>140 unite / L and ALT>40 unite / L and no lung dysfunction like FEV1>65% CR<2 HB>10 Having no active inflammation since 1 month ago Not using antioxidant and anti inflammatory drugs since 1 month ago
Exclusion criteria:
Aortic cross clamp time <20 min Pulse pressure <20 mmhg Redo surgeries Emergency surgeries
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
More than 1 sample in each individual
Number of samples in each individual: 1
blood sampels in special times will be collected from patients.
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of people to study groups (interventions and control) will be done by random block method and using blocks of 4. This work is done by the statistics professor with the relevant software. In each block, 2 people belong to the control group and 2 people belong to the intervention group, whose order is random and the blocks are selected using the table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done unilaterally (the laboratory and the sample collecting nurse) in such a way that the patients will be given explanations about the study and the two groups that are going to be studied, and then consent will be obtained from them to enter the study, but The laboratory personnel and the sample collecting nurse will not know about the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Medical Research Institute, Tehran
Street address
Valiasr Street, Hashemi Rafsanjani Highway, Shahid Rajaei Heart Hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2024-06-15, 1403/03/26
Ethics committee reference number
IR.RHC.REC.1403.035

Health conditions studied

1

Description of health condition studied
Patients undergoing complex cardiac surgery
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft

Primary outcomes

1

Description
Examination of malondialdehyde at specified times
Timepoint
Preoperatively, immediately after bypass, 24 hours later in the intensive care unit
Method of measurement
Blood test

2

Description
Total antioxidant capacity
Timepoint
Preoperatively, immediately after bypass, 24 hours later in the intensive care unit
Method of measurement
Blood test

3

Description
Lactat
Timepoint
Preoperatively, immediately after bypass, 24 hours later in the intensive care unit
Method of measurement
Blood test

Secondary outcomes

1

Description
ICU stay
Timepoint
Post operative
Method of measurement
patients file

2

Description
Ventilation time
Timepoint
Post operative
Method of measurement
Patients file

3

Description
reducing mortality and morbidity
Timepoint
Post operative
Method of measurement
patients file

Intervention groups

1

Description
Intervention group: Intervention group: Group A: 60 pulses per minute, the rest of the settings are the same and are as follows: 30% Base Flow and Pulse Width by default 40% but according to the patient's pressure curve and pulse amplitude It is adjusted so that the pulse pressure remains above 20 (in the pulsating group).
Category
Prevention

2

Description
Control group: group b will recieve non-pulsatile flow
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaee Heart Center
Full name of responsible person
Arezoo Moradi
Street address
Valiasr st, Hashemi rafsanjani highway,Rajaee heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
arezoo.m07@gmail.com
Web page address
https://rhc.ac.ir/fa/page/4366/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%A2%D9%85%D9%88%D8%B2%D8%B4%DB%8C

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaee heart center
Full name of responsible person
Saeid Hosseini
Street address
Wali Asr St. (AJ) - next to Mellat Park - Niayesh corner of Shahid Rajaei Cardiovascular Educational, Research and Therapeutic Institute
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
arezoo.m07@gmail.com
Web page address
https://rhc.ac.ir/fa/page/4366/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%A2%D9%85%D9%88%D8%B2%D8%B4%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaee heart center
Proportion provided by this source
100
Public or private sector
Private
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
Rajaee heart center
Full name of responsible person
Arezoo Moradi
Position
master student of cardiovascular perfusion
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Wali Asr St. (AJ) - next to Mellat Park - Niayesh corner of Shahid Rajaei Cardiovascular Educational, Research and Therapeutic Institute
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
arezoo.m07@gmail.com
Web page address
https://rhc.ac.ir/fa/page/4366/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%A2%D9%85%D9%88%D8%B2%D8%B4%DB%8C

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rajaee heart center
Full name of responsible person
Arezoo Moradi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Wali Asr St. (AJ) - next to Mellat Park - Niayesh corner of Shahid Rajaei Cardiovascular Educational, Research and Therapeutic Institute
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
arezoo.m07@gmail.com
Web page address
https://rhc.ac.ir/fa/page/4366/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%A2%D9%85%D9%88%D8%B2%D8%B4%DB%8C

Person responsible for updating data

Contact
Name of organization / entity
Ragaee heart center
Full name of responsible person
Arezoo moradi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Wali Asr St. (AJ) - next to Mellat Park - Niayesh corner of Shahid Rajaei Cardiovascular Educational, Research and Therapeutic Institute
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
arezoo.m07@gail.com
Web page address
https://rhc.ac.ir/fa/page/4366/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D8%A2%D9%85%D9%88%D8%B2%D8%B4%DB%8C

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The personal data of the study subjects cannot be shared and only part of the data related to age and such cases are shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available to researchers and scientific institutions.
Under which criteria data/document could be used
Researchers and academic institutions
From where data/document is obtainable
Arezoo Moradi, Master's student of Shahid Rajaei Heart Center Contact number: 09369390402 Email address: arezoo.m07@gmail.com
What processes are involved for a request to access data/document
The request was given to Ms. Arezoo Moradi and after follow-up, the hospital archive will be referred and after receiving the data, the documents will be shown to the requester. At least one week's time is required for follow-up and extracting the payment.
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