Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension

NCT01370096 | Terminated Phase 2 DMC

• 1 other identifier: 2011-LR-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

To diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure in their lungs. The right ventricle of the heart has to do more work to pump against this higher pressure. The investigators do not know the best medicine(s) to help children with pulmonary hypertension when their right ventricles fail. The purpose of the study is to look at the effects of two different medicines on the blood pressure in the lungs of a child with pulmonary hypertension. The investigators hope to then be able to choose the best medicine for children with pulmonary hypertension and right ventricular failure. The first medicine is called vasopressin. It is a hormone that your body makes on its own. The investigators will be giving it through an intravenous infusion. The investigators think that vasopressin works differently in different parts of your body. The investigators are looking to see the different effects that vasopressin has in the lungs compared to the rest of the body. The second medicine is called prostacyclin and is something that your body also makes by itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary hypertension as it decreases pressure in the blood vessels. In the catheterization laboratory, patients breathe in this medicine to measure specific changes in the blood pressure in their lungs.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• PVR/SVR indexed ratio

  Cardiac cath data

  Within 15 minutes of intervention

Interventions

Vasopressin infusion DRUG

An intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure.

Vasopressin infusion and epoprostenol inhalation DRUG

An intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure. If the target 20% increase in SBP is not achieved with vasopressin titration, the infusion will remain at 0.002U/kg/min. After a period of ten minutes of drug exposure to allow for patient equilibration, subjects will receive nebulized prostacyclin at a dose of 50ng/kg/min for 15 minutes via Aeroneb into the endotracheal tube.

Also known as: Flolan

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pediatric patients with pulmonary hypertension defined as a mean pulmonary artery pressure ≥ 25mmHg undergoing diagnostic cardiac catheterization for clinical purposes are potential subjects. Subjects must have preserved left ventricular function (ejection fraction ≥ 40 %). Subjects must have parental consent for enrollment.

You may not qualify if:

• Any patient with left ventricular dysfunction (EF \< 40%).
• Any patient with known pulmonary veno-occlusive disease

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Epoprostenol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins I; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: February 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)