AnesthesiaPhase 4NCT05132153
Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery
A Phase 4 study testing Milrinone and Normal saline in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Milrinone and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2021to 20 Sep 2022
- Phase
- Phase 4
- 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
None listed.
Who cannot join
- Cardiac surgery without CPB.
- Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
- Adult congenital heart disease planned for corrective surgery.
- Contraindication to transesophageal echocardiography (TEE).
- Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Samar Soliman
Cairo, Nasr City, 11511
Samar Soliman, 01006236494, dr_sm.md@hotmail.com
About this study
The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.
Read the detailed description
The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.
- Conditions
- Anesthesia
- Being tested
- Milrinone, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilrinoneDrug
will be given by nebulization
Normal salineDrug
will be given by nebuliztion
| Study group | Role | What they receive |
|---|---|---|
| (Group A) will receive milrinone | Active comparator | Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization Receives: Drug: Milrinone |
| (Group B) will receive normal saline | Placebo comparator | Patients will receive 5 ml saline by nebulization over 5 min Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of inhaled milrinone on improvement of right ventricular function
The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)
Measured: After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start17 Oct 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samar mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132153
- Sponsor's protocol ID
- FAMSU R 174/2021
- Status last verified
- Jul 2022
- First submitted
- 22 Oct 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05132153
- Acronym / sponsor ID
- FAMSU R 174/2021
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 24 Nov 2021 (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.
The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.
Detailed description
The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group A) will receive milrinone | Active comparator | Drug: MilrinonePatients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization |
| (Group B) will receive normal saline | Placebo comparator | Drug: Normal salinePatients will receive 5 ml saline by nebulization over 5 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Cardiac surgery without CPB.
- Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
- Adult congenital heart disease planned for corrective surgery.
- Contraindication to transesophageal echocardiography (TEE).
- Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.
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 |
|---|---|---|
| Milrinonewill be given by nebulization | Drug | (Group A) will receive milrinone |
| Normal salinewill be given by nebuliztion | Drug | (Group B) will receive normal saline |
Primary outcome
Effect of inhaled milrinone on improvement of right ventricular function
Time frame: After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit
The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Milrinone and Normal saline in people with Anesthesia, 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 0 inclusion and 5 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 Jul 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Samar Soliman (01006236494, dr_sm.md@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of inhaled milrinone on improvement of right ventricular function (time frame: After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit). 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 Jul 2022.