Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

Early Phase 1

Completed

• Conditions: Heart Rate; Blood Pressure; Airway Pressure
• Interventions: Drug: Hydrocortisone 200mg IV

• Registration Number: NCT04435912
• Lead Sponsor: University of Jordan

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.

Study Timeline

• Study Start: 2019-07-04
• Primary Completion: 2020-04-30
• Status Verified: 2020-06
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-16
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PS and HC group	Hydrocortisone 200mg IV	Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine

Primary Outcome Measures

Name	Time	Method
Blood pressure	changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given	both systolic, diastolic and mean arterial pressure

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters	the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose	The usage of Adrenaline, Noradrenaline and Dobutamine (microgram/kg/min).

Trial Locations

Locations (1)

Faculty of Medicine; 🇯🇴 Zarqa, Jordan