Clinical trial NCT01668277: Effects of Saline on Circulation in Children
Official title: Effects of Hypertonic Saline on the Pulmonary Circulation in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Hypertensive Crisis
Keywords: Pulmonary Hypertensive Crisis
Pediatrics
Hypertonic Saline
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia
* Age \> 2 years

Exclusion Criteria:

* Plasma Na \< 130 mmol/l or \>150 mmol/l
* Refusal of consent
* An estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
* Children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% NaCl over 10 minutes.

Primary outcomes:
measure: Pulmonary Vascular Resistance Index
timeFrame: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour
measure: Systemic Vascular Resistance Index
timeFrame: Change from Baseline in Systemic Vascular Resistance Index after 1 hour
measure: Cardiac Index
timeFrame: Change from Baseline in Cardiac Index after 1 hour
Secondary outcomes:
measure: Blood Gas
timeFrame: Average over 1 hour
measure: Plasma Volume
timeFrame: Average over 1 hour
measure: Atrial Natriuretic Peptide
timeFrame: Average over 1 hour
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital For Sick Children
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Katherine Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: