Cardiac AnaesthesiaMilrinoneNCT07144267
Comparison of Milrinone and Epinephrine on TAPSE
A study testing Epinephrine and Milrinone Injection in people with Cardiac Anaesthesia and Cardiopulmonary Bypass, run by Mansoura University at 1 site in Egypt.
Trial summary
Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Anaesthesia, Cardiopulmonary Bypass
- What is being tested?
- Epinephrine and Milrinone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II \& III
- Age between 18 and 70 years
- Both Gender
- Body mass index less than 40 kg/m2
- Ejection fraction of >40%
- Tricuspid annular plane systolic excursion (TAPSE) < 1.7cm
Who cannot join
- Patient refusal.
- Preoperative RV impairment
- Pulmonary hypertension (estimated pulmonary artery systolic pressure > 50 mmHg)
- Patients with any contraindications to Transesophageal echocardiography (TEE)
- Redo or Re-exploration surgery
- Patients with chronic kidney disease (serum creatinine > 1.5 mg/ dl)
- Patients with chronic liver disease (child pugh B and C)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial
Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.
Read the detailed description
Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis.
Milrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.
- Conditions
- Cardiac Anaesthesia, Cardiopulmonary Bypass
- Being tested
- Epinephrine, Milrinone Injection
- Keywords
- Cardiopulmonary bypass (CPB) -Tricuspid annular plane systolic excursion (TAPSE)-, Epinephrine - Milrinone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Normal saline bolus over 10 min followed by Epinephrine intravenous infusion of 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping
Milrinone InjectionDrug
Milrinone initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine group (group E) | Active comparator | The patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping Receives: Drug: Epinephrine |
| Milrinone group (group M) | Active comparator | patients will recieve an initial bolus dose of of 50 µg/kg, followed by 0.40 -0.80 µg/kg/min 5-10 minutes before aortic unclamping Receives: Drug: Milrinone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal value
measured by Transesophageal echocardiography (TEE)
Measured: Basal then within 5 mins post-cardiopulmonary bypass
Secondary outcomes (5)
Tricuspid annular plane systolic excursion (TAPSE)
measured by Transesophageal echocardiography (TEE)
Measured: within 30-60 minutes post-cardiopulmonary bypass
Incidence of Right Ventricular Dysfunction after Cardiac Surgery
detected by ECHO when Tricuspid annular plane systolic excursion (TAPSE) ≤1.7 cm
Measured: 24 hours postoperative
Incidence of Arrhythmias
occurrence of any Arrhythmia
Measured: intraoperatively and 24 hours postoperative
Vasoactive-Inotrope Score (VIS)
Vasoactive-Inotrope Score = Dopamine (µg/kg/min) + Dobutamine (µg/kg/min) +100 x Epinephrine (µg/kg/min) +100 x Norepinephrine (µg/kg/min) + 10 x Milrinone (µg/kg/min) + 10,000 x Vasopressin
Measured: recorded at 6, 12, 24, and 48 hours postoperative
Total consumption doses of Vasopressors
cumulative dose of any needed Vasopressors (Norepinepherine)
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Mar 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Epinephrine group (group E): the patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping. Milrinone group (group M): the patients receive initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144267
- Sponsor's protocol ID
- Milrinone on TAPSE
- Acronym
- Milrinone
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2025
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT07144267
- Acronym / sponsor ID
- Milrinone / Milrinone on TAPSE
- Conditions
- Cardiac Anaesthesia, Cardiopulmonary Bypass
- Keywords
- Cardiopulmonary bypass (CPB) -Tricuspid annular plane systolic excursion (TAPSE)-, Epinephrine - Milrinone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 27 Aug 2025 (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.
Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.
Detailed description
Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis.
Milrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Epinephrine group (group E): the patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping. Milrinone group (group M): the patients receive initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping
| Arm | Type | Receives |
|---|---|---|
| Epinephrine group (group E) | Active comparator | Drug: EpinephrineThe patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping |
| Milrinone group (group M) | Active comparator | Drug: Milrinone Injectionpatients will recieve an initial bolus dose of of 50 µg/kg, followed by 0.40 -0.80 µg/kg/min 5-10 minutes before aortic unclamping |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists (ASA) physical status II \& III
- Age between 18 and 70 years
- Both Gender
- Body mass index less than 40 kg/m2
- Ejection fraction of >40%
Key exclusion criteria (7 listed)
- Patient refusal.
- Preoperative RV impairment
- Pulmonary hypertension (estimated pulmonary artery systolic pressure > 50 mmHg)
- Patients with any contraindications to Transesophageal echocardiography (TEE)
- Redo or Re-exploration surgery
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 |
|---|---|---|
| EpinephrineNormal saline bolus over 10 min followed by Epinephrine intravenous infusion of 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping | Drug | Epinephrine group (group E) |
| Milrinone InjectionMilrinone initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping | Drug | Milrinone group (group M) |
Primary outcome
The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal value
Time frame: Basal then within 5 mins post-cardiopulmonary bypass
measured by Transesophageal echocardiography (TEE)
5 secondary outcomes
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: within 30-60 minutes post-cardiopulmonary bypass
Incidence of Right Ventricular Dysfunction after Cardiac Surgery
Time frame: 24 hours postoperative
Incidence of Arrhythmias
Time frame: intraoperatively and 24 hours postoperative
Vasoactive-Inotrope Score (VIS)
Time frame: recorded at 6, 12, 24, and 48 hours postoperative
Total consumption doses of Vasopressors
Time frame: 48 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine and Milrinone Injection in people with Cardiac Anaesthesia and Cardiopulmonary Bypass, run by Mansoura 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha A AboZeid, Assistant professor (01019216192 ext. 02, mahazed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal value (time frame: Basal then within 5 mins post-cardiopulmonary bypass). 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 13 Oct 2026.