COMPARISON OF THE EFFECTS OF INHALED MILRINONE WITH INHALED LEVOSIMENDAN IN PATIENTS WITH SEVERE PULMONARY HYPERTENSION UNDERGOING ELECTIVE MITRAL VALVE REPLACEMENT SURGERY

A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY TO COMPARE THE EFFECTS OF INHALED MILRINONE WITH INHALED LEVOSIMENDAN IN PATIENTS WITH SEVERE PULMONARY HYPERTENSION UNDERGOING ELECTIVE MITRAL VALVE REPLACEMENT SURGERY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055760

Enrollment

104

Registered

2023-07-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: - Health Condition 2: I059- Rheumatic mitral valve disease, unspecified

Interventions

Intervention1: Administration of inhaled milrinone: Inhaled milrinone will be administered in patients with mitral valve disease undergoing mitral valve replacement in a dose of 50 mic./kg body wt.th

Eligibility

Inclusion criteria

Inclusion criteria: PATIENTS WITH MITRAL VALVE DISEASE AND SEVERE PULMONARY HYPERTENSION UNDERGOING ELECTIVE MITRAL VALVE REPLACEMENT SURGERY

Exclusion criteria

Exclusion criteria: 1.Patients with concurrent coronary artery disease 2.Patients with coexisting aortic valve disease 3.Patients in NYHA grade III/IV 4.Patients requiring pre-operative inotropic support, 5.Patient requiring emergency surgery 6.Patients with coexisting hepatic, renal or severe respiratory disease.

Design outcomes

Primary

Measure	Time frame
1.Effect of both drugs on the haemodynamic andPA catheter derived parameters(CO,CI,SVR,SVRI,PVR,PVRI,Mpap,PCWP) and TEE assessment of right ventricular functions in the perioperative period. 2.Change in CS lactate concentration. Timepoint: â?¢T0 :Before induction (Baseline) â?¢T1: After induction(before nebulisation) â?¢T2 : After nebulisation before going on CPB â?¢T3: Post CPB at 10 minutes after protamine administration â?¢T4: Post surgery after skin closure	—

Measure

Time frame

1.Effect of both drugs on the haemodynamic andPA catheter derived parameters(CO,CI,SVR,SVRI,PVR,PVRI,Mpap,PCWP) and TEE assessment of right ventricular functions in the perioperative period. 2.Change in CS lactate concentration. Timepoint: â?¢T0 :Before induction (Baseline) â?¢T1: After induction(before nebulisation) â?¢T2 : After nebulisation before going on CPB â?¢T3: Post CPB at 10 minutes after protamine administration â?¢T4: Post surgery after skin closure

—

Secondary

Measure	Time frame
1. Time to extubation. 2. Length of ICU stay. 3. Incidence of related complications such as hypotension, arrhythmias and 30 days mortality. Timepoint: untill the patient is discharged.	—

Countries

India

Contacts

Public ContactDR SUKHDEV GARG

GIPMER

drsanjulavirmani@yahoo.co.in9718599409

Outcome results

None listed

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