Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

NCT02595541 | Completed Phase 1 DMC

• 1 other identifier: IRB000087140
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Hypertension

Keywords

pediatric; cardiac; sildenfil; milrinone; pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• mean pulmonary arterial pressure

  within the first 24 hours postoperative

Secondary Outcomes (2)

• mean systemic blood pressure

  within the first 24 hours postoperative

• pulmonary hypertensive crisis

  within the first 4 days postoperative

Study Arms (2)

milrinone group

ACTIVE COMPARATOR

milrinone

Drug: milrinone

sildenafil and milrinone group

ACTIVE COMPARATOR

milrinone and sildenafil

Drug: milrinone; Drug: Sildenafil

Interventions

milrinone 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.

Also known as: primacor

milrinone group; sildenafil and milrinone group

Sildenafil 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.

Also known as: viagra

sildenafil and milrinone group

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Milrinone; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Piperazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer-college of medicine

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11