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?Effects of adenosine in controlled reperfusion after heart valvular surgery

Evaluation the effects of controlled aortic root reperfusion with and without adenosine on clinical outcome in patients undergoing heart valve surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211225053519N1
Enrollment
60
Registered
2022-01-03
Start date
2022-02-04
Completion date
Unknown
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery of the valvular heart disease. Chronic rheumatic heart diseases, Congenital malformations of the circulatory system

Interventions

Intervention 1: Intervention group: In the intervention group and before off-pumping, warmblood with adenosine will be administered in a dose of 150 micrograms/kg (maximum dose: 12 milligrams), during

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Elective (not emergency) valvular surgery Cardiopulmonary bypass, and need for aortic cross-clamp and cardioplegia during operation Ejection fraction more than 35% before the surgery Negative history for previous cardiac surgery Lack of ventricular hypertrophy based on the preoperative echocardiography Lack of Inotropic consumption before the operation Lack of pacemakers or implantable cardioverter-defibrillator Pulmonary artery pressure less than 65mm Hg Filling the informed consent form

Exclusion criteria

Exclusion criteria: Returning to cardiopulmonary bypass during the operation Need for intra aortic balloon pump Need for mechanical heart support

Design outcomes

Primary

MeasureTime frame
Need for inotropic or anti arrhythmic drugs. Timepoint: Immediately after the surgery, during ICU stay. Method of measurement: Assessing receive/not receiving inotropic or anti arrhythmic drugs based on the medical record during the hospitalization.;Use of defibrillator. Timepoint: Immediately after the surgery. Method of measurement: Assessing the need for defibrillator based on the medical record during the hospitalization.;Type and time of the reentry rhythm. Timepoint: Immediately after the surgery. Method of measurement: Cardiac monitoring.;Cardiopulmonary Bypass Time. Timepoint: During the operation. Method of measurement: Time of the cardiopulmonary bypass in minutes.;Aortic Cross Clamp Time. Timepoint: During the operation. Method of measurement: Time of the aortic cross clamp in minutes.;ICU stay. Timepoint: After the operation. Method of measurement: ICU stay based on days.;Mechanical Ventilation time. Timepoint: During the operation. Method of measurement: Mechanical ventilation time in minute.;Troponin laboratory assessment. Timepoint: After the operation. Method of measurement: Biochemical assessment.;CPK assessment. Timepoint: After the operation. Method of measurement: Biochemical analysis.;Renal function assessment. Timepoint: After the operation. Method of measurement: Biochemical Assessment.;Liver function assessment. Timepoint: After the operation. Method of measurement: Biochemical assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Amin Shahrbaf

Iran University of Medical Sciences

Aminshahrbaf41@gmail.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026