Effects of Saline on Circulation in Children

NCT01668277 | Terminated Phase 2

• 1 other identifier: 1000026525
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Hypertensive Crisis

Keywords

Pulmonary Hypertensive Crisis; Pediatrics; Hypertonic Saline

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Blood Gas

  Average over 1 hour

• Plasma Volume

  Average over 1 hour

• Atrial Natriuretic Peptide

  Average over 1 hour

Study Arms (3)

3 ml/kg 7.2% NaCl

EXPERIMENTAL

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

3 ml/kg 0.9% NaCl

ACTIVE COMPARATOR

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

20 ml/kg 0.9% NaCl

ACTIVE COMPARATOR

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

Interventions

7.2% NaCl DRUG

3 ml/kg 7.2% NaCl

0.9% NaCl DRUG

20 ml/kg 0.9% NaCl; 3 ml/kg 0.9% NaCl

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Hospital For Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Katherine Taylor, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

CA (2)