Clinical trial NCT04435912: Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate
Official title: The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Pressure
Heart Rate
Airway Pressure
Keywords: Protamine sulfate
Hydrocortisone
Protamine Sulfate side effects
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Blood pressure
timeFrame: changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Secondary outcomes:
measure: Hemodynamic parameters
timeFrame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
measure: Hemodynamic parameters
timeFrame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
measure: Hemodynamic parameters
timeFrame: the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose
Other outcomes:
Locations:
city: Zarqa
country: Jordan
facility: Faculty of Medicine
Study officials:
affiliation: The University of Jordan
name: Mustafa A Alrabayah, MD
role: STUDY_DIRECTOR
References: