Pulmonary HypertensionPhase 1NCT04594629
PGI2 Versus Nitroglycerine for Management of Pulmonary Hypertension After Valve Surgeries
A Phase 1 study testing Nitroglycerin and PGI2 in people with Pulmonary Hypertension, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to nitro glycerine or PGI2 groups. Read more about this study
- Who is it for?
- Ages 54 to 65 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Nitroglycerin and PGI2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2020to Jun 2021
- Phase
- 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 54 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 to 66 years old
- elective valve replacement surgery
- pulmonary arterial hypertension
Who cannot join
- Emergency surgery
- severe renal and hepatic dysfunction
- uncontrolled supraventricular arrhythmia
- those requiring preoperative inotropes
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university
Cairo, 11566
Ayman Shoeb, 01223111124, ayman.shoeb@gmail.com
About this study
Official title: Efficacy of Nebulized PGI2 Versus Nebulized Nitroglycerine for Management of Pulmonary Hypertension After Valve Replacement Surgeries
This study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h . The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) , 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.
Read the detailed description
Postoperative pulmonary hypertension (PHT) is the most challenging complication of valvular heart disease about 73% of the patients particularly in those posted for mitral valve replacement surgery Methods This prospective study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to either nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine (its starting concentration was 200 mcg/ml); nitro glycerine was delivered at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment. The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) measured at the end of cardiopulmonary bypass then 30 minutes after start of treatment then 4 hours after start of treatment, 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.
- Conditions
- Pulmonary Hypertension
- Being tested
- Nitroglycerin, PGI2
- Keywords
- PGI2, Nitroglycerine, valve replacement surgery, pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
Also called N group
Patients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit
PGI2Drug
Also called PG group
Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres
| Study group | Role | What they receive |
|---|---|---|
| nitroglycerine group | Sham comparator | Patients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit Receives: Drug: Nitroglycerin |
| PGI2 group | Active comparator | Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres. Receives: Drug: PGI2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pulmonary artery pressure
decrease of mean pulmonary artery pressure
Measured: baseline, 30 minutes after start of study drug, 4 hours after start of study drug
Secondary outcomes (2)
mortality
rate of mortality
Measured: 30 days postoperative
central venous pressure
measurement of central venous pressure
Measured: at the end of cardiopulmonary bypass (baseline values) then 30 minutes after start of treatment then 4 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Shokri, Ain Shams University
- Investigators
- Ayman Shoeb, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594629
- Sponsor's protocol ID
- FMASU R 70/2020
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulized PGI2 Versus Nebulized Nitroglycerine for Management of Pulmonary Hypertension After Valve Replacement Surgeries
- ClinicalTrials.gov ID
- NCT04594629
- Acronym / sponsor ID
- FMASU R 70/2020
- Conditions
- Pulmonary Hypertension
- Keywords
- PGI2, Nitroglycerine, valve replacement surgery, pulmonary hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Oct 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 was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h . The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) , 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.
Detailed description
Postoperative pulmonary hypertension (PHT) is the most challenging complication of valvular heart disease about 73% of the patients particularly in those posted for mitral valve replacement surgery Methods This prospective study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to either nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine (its starting concentration was 200 mcg/ml); nitro glycerine was delivered at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment. The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) measured at the end of cardiopulmonary bypass then 30 minutes after start of treatment then 4 hours after start of treatment, 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nitroglycerine group | Sham comparator | Drug: NitroglycerinPatients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit |
| PGI2 group | Active comparator | Drug: PGI2Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres. |
Who may qualify
- Ages
- 54 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 35 to 66 years old
- elective valve replacement surgery
- pulmonary arterial hypertension
Key exclusion criteria (4 listed)
- Emergency surgery
- severe renal and hepatic dysfunction
- uncontrolled supraventricular arrhythmia
- those requiring preoperative inotropes
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 |
|---|---|---|
| NitroglycerinAlso: N groupPatients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit | Drug | nitroglycerine group |
| PGI2Also: PG groupPatients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres | Drug | PGI2 group |
Primary outcome
mean pulmonary artery pressure
Time frame: baseline, 30 minutes after start of study drug, 4 hours after start of study drug
decrease of mean pulmonary artery pressure
2 secondary outcomes
mortality
Time frame: 30 days postoperative
central venous pressure
Time frame: at the end of cardiopulmonary bypass (baseline values) then 30 minutes after start of treatment then 4 hours after start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: Yes. study protocol
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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.
Ayman Shoeb study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitroglycerin and PGI2 in people with Pulmonary Hypertension, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Oct 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoda Shokri (01211179234, drhoda10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean pulmonary artery pressure (time frame: baseline, 30 minutes after start of study drug, 4 hours after start of study drug). 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 20 Oct 2020.