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Completed

NCT Number: NCT04435912

Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine

Zarqa, 13133, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone 200mg IV

Drug

single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine

Primary outcomes

  1. Blood pressure

    Time frame: 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 outcomes

  1. Hemodynamic parameters

    Time frame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given

    Heart rate (Beat Per Minute),

  2. Hemodynamic parameters

    Time frame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given

    Airway pressure (cm H2O)

  3. Hemodynamic parameters

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2020
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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