NCT04435912

Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the hemodynamic parameters within and between patients who received Protamine Sulfate (PS) with Hydrocortisone (HC) vs. Protamine Sulfate alone during cardiac surgeries.

Detailed description

the investigators hypothesized that patients received PS along with HC would have different results in intraoperative hemodynamic changes of the blood pressure - both Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) reading. Differences would also be expected for Heart rate (HR), Airway pressure and the usage of Adrenaline, Noradrenaline and Dobutamine. Patients who had cardiac surgery using cardiopulmonary bypass were screened and enrolled from 4/7/2019 to 30/4/2020. Inclusion criteria for patients were normal preoperative hemoglobin level, normal preoperative platelet count, no known defect of the coagulation system, and patients with unimpaired renal function (creatinine clearance \< 30 ml/kg/min). The patients were excluded if they were younger than 18 years, patients with known defect of the coagulation system, renal impairment, previous vasectomy, allergy to fish or unable to give consent form. The study carried out as a parallel-group, randomized, controlled trial with a 1:1 allocation ratio. Patients were screened for eligibility in the wards before being invited to participate in the research. After the invitation, the study was explained to patients. Those who agreed to participate in the study were asked to sign the consent form.

Conditions

• Blood Pressure
• Heart Rate
• Airway Pressure

Interventions

Type	Name	Description
DRUG	Hydrocortisone 200mg IV	single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine

Timeline

• Start date: 2019-07-04
• Primary completion: 2020-04-30
• Completion: 2020-06-01
• First posted: 2020-06-17
• Last updated: 2020-06-17

Locations

1 site across 1 country: Jordan

Regulatory

• FDA-regulated drug study