Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

NCT ID: NCT02595541

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-10-31

Brief Summary

Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements. Pulmonary arterial hypertension is a frequent complication of congenital heart disease, particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP ratio of < 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension, and a ratio of > 0.5 is indicative of severe pulmonary hypertension

Detailed Description

30 Patients were randomly allocated in two equal groups; group MS (received intravenous milrinone and oral sildenafil) and group M (received only intravenous milrinone). Demographic data, patient's clinical data and different intraoperative times were recorded. In 1st postoperative 24 hours, we recorded; hemodynamic parameters [mean pulmonary arterial pressure (MPAP), mean systemic arterial pressure (MAP), heart rate, central venous pressure]. We calculated MPAP/MAP and inotropic score. The incidence of pulmonary hypertensive crisis, side effects of studied drugs and complications related to pulmonary artery catheter were recorded.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

milrinone group

milrinone

Group Type: ACTIVE_COMPARATOR

milrinone

Intervention Type: DRUG

IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study.

sildenafil and milrinone group

milrinone and sildenafil

Group Type: ACTIVE_COMPARATOR

milrinone

Intervention Type: DRUG

IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study.

Sildenafil

Intervention Type: DRUG

IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study. After baseline measurements, sildenafil (1mg/kg) administered in ICU via a nasogastric tube, to be repeated every 4 hours via a nasogastric tube or orally. Sildnafil is presented in tablet form which was dissolved in water to make a concentration of 1 mg/ml.

Interventions

milrinone

IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study.

Intervention Type: DRUG

Sildenafil

IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study. After baseline measurements, sildenafil (1mg/kg) administered in ICU via a nasogastric tube, to be repeated every 4 hours via a nasogastric tube or orally. Sildnafil is presented in tablet form which was dissolved in water to make a concentration of 1 mg/ml.

Intervention Type: DRUG

Other Intervention Names

primacor; viagra

Eligibility Criteria

Inclusion Criteria

• Thirty patients in the age range 2-24 months scheduled for surgical closure of ventricular septal defect (VSD) associated with postoperative pulmonary hypertension [diagnosed in all patients by preoperative echocardiography and confirmed invasively by the pulmonary catheter before transfer to ICU by Mean Pulmonary Arterial Pressure (MPAP) > 25 mmHg or Mean Pulmonary Arterial Pressure (MPAP) /Mean Systemic Arterial Pressure (MAP) > 0.33] were enrolled in this study.

Exclusion Criteria

• Patients with pre-existing obstructive lung disease, mitral valve disease, left ventricular dysfunction, and patients receiving preoperative pulmonary vasodilators

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esam Eldin Mohamed Abdalla

lecturer-college of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB000087140

Identifier Type: -

Identifier Source: org_study_id