Comparison of Milrinone and Epinephrine on TAPSE

NCT07144267 | Not Yet Recruiting

• 1 other identifier: Milrinone on TAPSE
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cardiac Anaesthesia; Cardiopulmonary Bypass

Keywords

Cardiopulmonary bypass (CPB) -Tricuspid annular plane systolic excursion (TAPSE)-; Epinephrine - Milrinone

Outcome Measures

Primary Outcomes (1)

• 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)

  Basal then within 5 mins post-cardiopulmonary bypass

Secondary Outcomes (5)

• Tricuspid annular plane systolic excursion (TAPSE)

  within 30-60 minutes post-cardiopulmonary bypass

• Incidence of Right Ventricular Dysfunction after Cardiac Surgery

  24 hours postoperative

• Incidence of Arrhythmias

  intraoperatively and 24 hours postoperative

• Vasoactive-Inotrope Score (VIS)

  recorded at 6, 12, 24, and 48 hours postoperative

• Total consumption doses of Vasopressors

  48 hours postoperative

Study Arms (2)

Epinephrine group (group E)

ACTIVE COMPARATOR

The patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping

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

Drug: Milrinone Injection

Interventions

Epinephrine DRUG

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

Epinephrine group (group E)

Milrinone Injection DRUG

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

Milrinone group (group M)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Interventions

Epinephrine; Milrinone

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amrinone; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Maha A AboZeid, Assistant professor

CONTACT

01019216192; mahazed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: anesthesiologist who performed TEE measurements and who was responsible for data collection will be blinded to patient group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia , surgical Intensive care and pain management Faculty of Medicine

Model Details: 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

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02