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Effects of Saline on Circulation in Children

NCT ID: NCT01668277

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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 Description

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Conditions

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Pulmonary Hypertensive Crisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

7.2% NaCl

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

0.9% NaCl

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

0.9% NaCl

Intervention Type DRUG

Interventions

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7.2% NaCl

Intervention Type DRUG

0.9% NaCl

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Katherine Taylor

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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Hospital For Sick Children

Toronto, Ontario, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000026525

Identifier Type: -

Identifier Source: org_study_id