Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06301880 |
| Other study ID # |
3200 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Damascus University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
