Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435912
• Other study ID #: MAlrabayah
• Status: Completed
• Phase: Early Phase 1
• Start date: July 4, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 1, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Pressure
• Blood Pressure
• Heart Rate

Intervention

Drug:
• Hydrocortisone 200mg IV
single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine

Locations

Country	Name	City	State
Jordan	Faculty of Medicine	Zarqa

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hemodynamic parameters	Heart rate (Beat Per Minute),	changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Secondary	Hemodynamic parameters	Airway pressure (cm H2O)	changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Secondary	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