Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

NCT04435912 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: MAlrabayah
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Heart Rate; Airway Pressure

Keywords

Protamine sulfate; Hydrocortisone; Protamine Sulfate side effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemodynamic parameters

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

• Hemodynamic parameters

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

• 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

Study Arms (2)

PS alone group

NO INTERVENTION

Patients received only Protamine Sulfate for reversal of Heparin

PS and HC group

EXPERIMENTAL

Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine

Drug: Hydrocortisone 200mg IV

Interventions

Hydrocortisone 200mg IV DRUG

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

PS and HC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Faculty of Medicine

Zarqa, 13133, Jordan

Location

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Mustafa A Alrabayah, MD

  The University of Jordan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization envelopes kept closed until the completion of patient registration.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 17, 2020
• Study Start: July 4, 2019
• Primary Completion: April 30, 2020
• Study Completion: June 1, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)