Blood PressureEarly Phase 1NCT04435912
Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate
A Early Phase 1 study testing Hydrocortisone 200mg IV in people with Blood Pressure and Heart Rate, run by University of Jordan at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Heart Rate, Airway Pressure
- What is being tested?
- Hydrocortisone 200mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJordan
- Study dates
- 4 Jul 2019to 1 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.
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.
Read the 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.
- Conditions
- Blood Pressure, Heart Rate, Airway Pressure
- Being tested
- Hydrocortisone 200mg IV
- Keywords
- Protamine sulfate, Hydrocortisone, Protamine Sulfate side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone 200mg IVDrug
single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Hydrocortisone 200mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
both systolic, diastolic and mean arterial pressure
Measured: changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Secondary outcomes (3)
Hemodynamic parameters
Heart rate (Beat Per Minute),
Measured: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Hemodynamic parameters
Airway pressure (cm H2O)
Measured: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Hemodynamic parameters
The usage of Adrenaline, Noradrenaline and Dobutamine (microgram/kg/min).
Measured: the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start4 Jul 2019
- Primary completion30 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Alrabayah, University of Jordan
- Investigators
- Mustafa A Alrabayah, MD, Study director, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435912
- Sponsor's protocol ID
- MAlrabayah
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: decision depends on the roles and regulations of The University of Jordan
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04435912
- Acronym / sponsor ID
- MAlrabayah
- Conditions
- Blood Pressure, Heart Rate, Airway Pressure
- Keywords
- Protamine sulfate, Hydrocortisone, Protamine Sulfate side effects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
| Arm | Type | Receives |
|---|---|---|
| PS alone group | No intervention | –Patients received only Protamine Sulfate for reversal of Heparin |
| PS and HC group | Experimental | Drug: Hydrocortisone 200mg IVPatients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Patients younger than 18 years
- Patients with known defect of the coagulation system
- Renal impairment
- Previous vasectomy
- Allergy to fish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone 200mg IVsingle dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine | Drug | PS and HC group |
Primary outcome
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
3 secondary outcomes
Hemodynamic parameters
Time frame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
Hemodynamic parameters
Time frame: changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No. decision depends on the roles and regulations of The University of Jordan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa A Alrabayah, MD study director
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydrocortisone 200mg IV in people with Blood Pressure and Heart Rate, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.