Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

University of Jordan

Status and phase: Completed; Early Phase 1

Conditions: Airway Pressure; Heart Rate; Blood Pressure

Treatments: Drug: Hydrocortisone 200mg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT04435912

MAlrabayah

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

PS alone group

No Intervention group

Description:

Patients received only Protamine Sulfate for reversal of Heparin

PS and HC group

Experimental group

Description:

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

Treatment:

Drug: Hydrocortisone 200mg IV