Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

NCT ID: NCT04435912

Last Updated: 2020-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2020-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PS alone group

Patients received only Protamine Sulfate for reversal of Heparin

Group Type: NO_INTERVENTION

No interventions assigned to this group

PS and HC group

Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine

Group Type: EXPERIMENTAL

Hydrocortisone 200mg IV

Intervention Type: DRUG

single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine

Interventions

Hydrocortisone 200mg IV

single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who had cardiac surgery using cardiopulmonary bypass
• Normal preoperative hemoglobin level
• Normal preoperative platelet count
• No known defect of the coagulation system
• Patients with unimpaired renal function (creatinine clearance < 30 ml/kg/min)

Exclusion Criteria

• Patients younger than 18 years
• Patients with known defect of the coagulation system
• Renal impairment
• Previous vasectomy
• Allergy to fish
• Unable to give consent form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Alrabayah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa A Alrabayah, MD

Role: STUDY_DIRECTOR

The University of Jordan

Locations

Faculty of Medicine

Zarqa, , Jordan

Countries

Jordan

Other Identifiers

MAlrabayah

Identifier Type: -

Identifier Source: org_study_id