Study to compare efficiency of two medicines namely levosimendan and milrinone in reducing pressure in pulmonary artery.

Comparative efficacy of levosimendan versus milrinone in patients with severe pulmonary hypertension undergoing elective mitral valve replacement surgery - A randomized study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017275

Enrollment

Registered

2019-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: Pulmonary artery catheter: Pulmonary artery catheter will be inserted for pulmonary artery catheter derived data (Cardiac index, pulmonary artery systolic pressure, mean pulmonary arter

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients of either sex 2 Age betwwen 18 to 70 year 3 Mitral valve disease 4 Severe pulmonary hypertension (Right ventricular systolic pressure more than or equals to 50 mm Hg) 5 Scheduled for elective mitral valve replacement surgery

Exclusion criteria

Exclusion criteria: 1 Presence of concurrent coronary artery disease. Patients more than 45yr old will have coronary angiography done to rule out coronary artery disease. 2 Coexisting aortic valve disease 3 Patients in NYHA IV 4 Patients requiring pre-operative inotropes 5 Pregnancy 6 Coexisting hepatic, renal or severe respiratory disease

Design outcomes

Primary

Measure	Time frame
1.Effect of both drugs on the haemodynamic parameters (systemic as well as PA catheter derived) in the perioperative period 2.Change in coronary sinus lactate concentrationTimepoint: Haemodynamic parameters will be recorded at the following time intervals: T1: Baseline T2: At 10 minutes after protamine administration T3: After skin closure Coronary sinus blood lactate levels will be recorded at CS1: After opening of pericardium, before going on CPB from the CS CS2: At 10 minutes after protamine administration (along with T2) CS3: After skin closure (along with T3) CS4: 6 hours after surgery CS5: 24 hours after surgery	—

Measure

Time frame

1.Effect of both drugs on the haemodynamic parameters (systemic as well as PA catheter derived) in the perioperative period 2.Change in coronary sinus lactate concentrationTimepoint: Haemodynamic parameters will be recorded at the following time intervals: T1: Baseline T2: At 10 minutes after protamine administration T3: After skin closure Coronary sinus blood lactate levels will be recorded at CS1: After opening of pericardium, before going on CPB from the CS CS2: At 10 minutes after protamine administration (along with T2) CS3: After skin closure (along with T3) CS4: 6 hours after surgery CS5: 24 hours after surgery

—

Secondary

Measure	Time frame
1.Time to extubation 2.Duration of ICU stay 3.Incidence of related complications such as hypotension, arrhythmias and 30 days mortalityTimepoint: 1.Extubation time 2.Duration patient stays in ICU 3.30 days from day of surgery	—

Countries

India

Contacts

Public ContactDr Abhas Chandra Dash

GB pant hospital

drsanjulavirmani@yahoo.co.in9718599409

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026