Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow

NCT ID: NCT06301880

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-01-31

Brief Summary

Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2).

Detailed Description

Fifty consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study. Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

All surgical procedures and measurements were carried out by a single surgeon who was blinded to the topical agent which was applied. Each patient enrolled in the study gave a written informed consent, and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the local human research committee.

Operative Technique After sternal incision, the skeletonized left IMA was harvested from the subclavian artery to its bifurcation with low-powered electrocautery, and major collaterals were ligated with hemoclips. Following systemic heparinization (300 units/kg to achieve an activated clotting time target of 480 seconds), the IMA was divided proximal to its bifurcation. The first IMA flow (flow 1) was measured by reading the volume of blood ejected from the tip of the freely bleeding IMA through a one-minute period. Heart rate, mean arterial pressure and central venous pressure were documented at the same time. The tip of the artery was occluded with a bulldog clamp, and a swab which was soaked with the selected vasodilator at room temperature (18.0 to 20.0 degrees C) was wrapped around the IMA, and was left undisturbed until the second set of measurements.

Cannulation for cardiopulmonary bypass was carried out, and the pump was used to transfuse or drain blood from the patient in order to restore the mean arterial and central venous pressures as nearly as possible to the previous values. Systemic vasopressors or vasodilators were not used. The IMA was then unwrapped and the second IMA flow (flow 2) was measured in the same way. Time, heart rate, and mean arterial and central venous pressures were also recorded.

Conditions

Internal Mammary Artery Syndrome; Vasodilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: Normal saline

Patients in this group were randomly assigned to receive the topical application of normal saline (0.9% sodium chloride solution) on the LIMA graft as control

Group Type: PLACEBO_COMPARATOR

The topical application of a vasodilator on the LIMA graft

Intervention Type: DRUG

Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

Group 2: Nitroglycerin

Patients were randomly assigned to receive the topical application of nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline on the LIMA graft.

Group Type: ACTIVE_COMPARATOR

The topical application of a vasodilator on the LIMA graft

Intervention Type: DRUG

Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

Group 3: milrinone

Patients were randomly assigned to receive the topical application of milrinone (Baxter Pharmaceuticals, Ahmedabad, India) on the LIMA graft

Group Type: ACTIVE_COMPARATOR

The topical application of a vasodilator on the LIMA graft

Intervention Type: DRUG

Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

Interventions

The topical application of a vasodilator on the LIMA graft

Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

Intervention Type: DRUG

Other Intervention Names

milrinone (Baxter Pharmaceuticals, Ahmedabad, India), nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran)

Eligibility Criteria

Inclusion Criteria

• patients undergoing elective primary coronary artery bypass grafting

Exclusion Criteria

• patients who developed ischemic events during surgery

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Bashar Izzat

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad Bashar Izzat, FRCS(CTh)

Role: PRINCIPAL_INVESTIGATOR

Damascus University

Locations

Damascus University Cardiac Surgery Hospital

Damascus, , Syria

Countries

Syria

Other Identifiers

3200

Identifier Type: -

Identifier Source: org_study_id