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Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
milrinone
Sildenafil
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pediatric, cardiac, sildenfil, milrinone, pulmonary hypertension

Eligibility Criteria

2 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    milrinone group

    sildenafil and milrinone group

    Arm Description

    milrinone

    milrinone and sildenafil

    Outcomes

    Primary Outcome Measures

    mean pulmonary arterial pressure

    Secondary Outcome Measures

    mean systemic blood pressure
    pulmonary hypertensive crisis

    Full Information

    First Posted
    November 2, 2015
    Last Updated
    November 10, 2015
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02595541
    Brief Title
    Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension
    Official Title
    Effects of Adding Oral Sildenafil to Intravenous Milrinone on Postoperative Pulmonary Hypertension in Pediatric Undergoing Repair of Ventricular Septal Defect
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension
    Keywords
    pediatric, cardiac, sildenfil, milrinone, pulmonary hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    milrinone group
    Arm Type
    Active Comparator
    Arm Description
    milrinone
    Arm Title
    sildenafil and milrinone group
    Arm Type
    Active Comparator
    Arm Description
    milrinone and sildenafil
    Intervention Type
    Drug
    Intervention Name(s)
    milrinone
    Other Intervention Name(s)
    primacor
    Intervention Description
    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
    Intervention Name(s)
    Sildenafil
    Other Intervention Name(s)
    viagra
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    mean pulmonary arterial pressure
    Time Frame
    within the first 24 hours postoperative
    Secondary Outcome Measure Information:
    Title
    mean systemic blood pressure
    Time Frame
    within the first 24 hours postoperative
    Title
    pulmonary hypertensive crisis
    Time Frame
    within the first 4 days postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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    Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

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