Effects of Saline on Circulation in Children

Effects of Hypertonic Saline on the Pulmonary Circulation in Children

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Hypertensive Crisis
• Intervention / Treatment: Drug: 0.9% NaCl; Drug: 7.2% NaCl

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3 ml/kg 7.2% NaCl; The test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.	Drug: 7.2% NaCl
ACTIVE_COMPARATOR: 3 ml/kg 0.9% NaCl; The test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.	Drug: 0.9% NaCl
ACTIVE_COMPARATOR: 20 ml/kg 0.9% NaCl; The test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.	Drug: 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Cardiac Index	Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.	Change from Baseline in Cardiac Index after 1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Katherine Taylor, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (ESTIMATE): August 20, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pediatrics; Hypertonic Saline; Pulmonary Hypertensive Crisis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Hypertensive Encephalopathy
• Other Study ID Numbers: 1000026525