Clinical Trial: Effects of Saline on Circulation in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Hypertonic Saline on the Pulmonary Circulation in Children

Brief Summary: Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. This study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome:

• Pulmonary Vascular Resistance Index [ Time Frame: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour ]
  Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
• Systemic Vascular Resistance Index [ Time Frame: Change from Baseline in Systemic Vascular Resistance Index after 1 hour ]
  Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
• Cardiac Index [ Time Frame: Change from Baseline in Cardiac Index after 1 hour ]
  Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Blood Gas [ Time Frame: Average over 1 hour ]
  Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer
• Plasma Volume [ Time Frame: Average over 1 hour ]
  Effect on plasma volume calculated from the change in blood hemoglobin
• Atrial Natriuretic Peptide [ Time Frame: Average over 1 hour ]
  Effect on atrial natriuretic peptide

Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: August 8, 2012
Date Started: August 2012
Date Completion:
Last Updated: December 19, 2014
Last Verified: December 2014