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Comparison of Milrinone and Epinephrine on TAPSE

ConditionsCardiac AnaesthesiaCardiopulmonary Bypass
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMansoura University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal.

Preoperative RV impairment

Pulmonary hypertension (estimated pulmonary artery systolic pressure > 50 mmHg)

Patients with any contraindications to Transesophageal echocardiography (TEE)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Epinephrine group (group E)Active comparator 1 intervention
Group B: Milrinone group (group M)Active comparator 1 intervention

Trial outcomes

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)

Time frame
Basal then within 5 mins post-cardiopulmonary bypass

Secondary outcomes

1

Tricuspid annular plane systolic excursion (TAPSE)

measured by Transesophageal echocardiography (TEE)

Time frame
within 30-60 minutes post-cardiopulmonary bypass
2

Incidence of Right Ventricular Dysfunction after Cardiac Surgery

detected by ECHO when Tricuspid annular plane systolic excursion (TAPSE) ≤1.7 cm

Time frame
24 hours postoperative
3

Incidence of Arrhythmias

occurrence of any Arrhythmia

Time frame
intraoperatively and 24 hours postoperative
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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