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.

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Heart Rate; Airway Pressure
• Intervention / Treatment: Drug: Hydrocortisone 200mg IV

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Zarqa, Jordan, 13133
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: PS alone group; Patients received only Protamine Sulfate for reversal of Heparin
Experimental: PS and HC group; Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine	Drug: Hydrocortisone 200mg IV; single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic parameters	Heart rate (Beat Per Minute),	changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Hemodynamic parameters	Airway pressure (cm H2O)	changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Hemodynamic parameters	The usage of Adrenaline, Noradrenaline and Dobutamine (microgram/kg/min).	the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Study Director: Mustafa A Alrabayah, MD, The University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hydrocortisone; Protamine sulfate; Protamine Sulfate side effects
• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: MAlrabayah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: decision depends on the roles and regulations of The University of Jordan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes