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Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT02595541
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Esam Eldin Mohamed Abdalla, Assiut University

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

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: milrinone Drug: Sildenafil Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Adding Oral Sildenafil to Intravenous Milrinone on Postoperative Pulmonary Hypertension in Pediatric Undergoing Repair of Ventricular Septal Defect
Study Start Date : June 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: milrinone group
milrinone
Drug: 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.
Other Name: primacor

Active Comparator: sildenafil and milrinone group
milrinone and sildenafil
Drug: 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.
Other Name: primacor

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.
Other Name: viagra




Primary Outcome Measures :
  1. mean pulmonary arterial pressure [ Time Frame: within the first 24 hours postoperative ]

Secondary Outcome Measures :
  1. mean systemic blood pressure [ Time Frame: within the first 24 hours postoperative ]
  2. pulmonary hypertensive crisis [ Time Frame: within the first 4 days postoperative ]


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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Esam Eldin Mohamed Abdalla, lecturer-college of medicine, Assiut University
ClinicalTrials.gov Identifier: NCT02595541     History of Changes
Other Study ID Numbers: IRB000087140
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Esam Eldin Mohamed Abdalla, Assiut University:
pediatric
cardiac
sildenfil
milrinone
pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Milrinone
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Cardiotonic Agents
Platelet Aggregation Inhibitors
Phosphodiesterase 3 Inhibitors
Protective Agents
Physiological Effects of Drugs