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Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

Sponsor
University of Jordan (Other)
Overall Status
Completed
CT.gov ID
NCT04435912
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
10.9
Actual Duration (Months)
18.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydrocortisone 200mg IV
 Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
Masking:
Double (Care Provider, Investigator)
Masking Description:
Randomization envelopes kept closed until the completion of patient registration.
Primary Purpose:
Prevention
Official Title:
The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.
Actual Study Start Date :
Jul 4, 2019
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Hemodynamic parameters [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 [changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given]

    Airway pressure (cm H2O)

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Zarqa Jordan 13133

Sponsors and Collaborators

  • University of Jordan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mustafa Alrabayah, Assistant Professor, University of Jordan
ClinicalTrials.gov Identifier:
NCT04435912
Other Study ID Numbers:
  • MAlrabayah
First Posted:
Jun 17, 2020
Last Update Posted:
Jun 17, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Mustafa Alrabayah, Assistant Professor, University of Jordan
Protamine sulfate
Hydrocortisone
Protamine Sulfate side effects
Additional relevant MeSH terms:
Hydrocortisone

Study Results

No Results Posted as of Jun 17, 2020