Effects of Saline on Circulation in Children

Pulmonary Hypertensive Crisis Clinical Trial

Official title:

Effects of Hypertonic Saline on the Pulmonary Circulation in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01668277
• Other study ID #: 1000026525
• Status: Terminated
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Hypertensive Crisis

Intervention

Drug:
• 7.2% NaCl

• 0.9% NaCl

Locations

Country	Name	City	State
Canada	Hospital For Sick Children	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Vascular Resistance Index	Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.	Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour
Primary	Systemic Vascular Resistance Index	Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.	Change from Baseline in Systemic Vascular Resistance Index after 1 hour
Primary	Cardiac Index	Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.	Change from Baseline in Cardiac Index after 1 hour
Secondary	Blood Gas	Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer	Average over 1 hour
Secondary	Plasma Volume	Effect on plasma volume calculated from the change in blood hemoglobin	Average over 1 hour
Secondary	Atrial Natriuretic Peptide	Effect on atrial natriuretic peptide	Average over 1 hour