Effects of Saline on Circulation in Children

This study is currently recruiting participants.
Verified May 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Katherine Taylor, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01668277
First received: August 8, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertensive Crisis
Drug: 7.2% NaCl
Drug: 0.9% NaCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Hypertonic Saline on the Pulmonary Circulation in Children

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Pulmonary Vascular Resistance Index [ Time Frame: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour ] [ Designated as safety issue: No ]
    Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.

  • Systemic Vascular Resistance Index [ Time Frame: Change from Baseline in Systemic Vascular Resistance Index after 1 hour ] [ Designated as safety issue: No ]
    Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.

  • Cardiac Index [ Time Frame: Change from Baseline in Cardiac Index after 1 hour ] [ Designated as safety issue: No ]
    Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.


Secondary Outcome Measures:
  • Blood Gas [ Time Frame: Average over 1 hour ] [ Designated as safety issue: No ]
    Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer

  • Plasma Volume [ Time Frame: Average over 1 hour ] [ Designated as safety issue: No ]
    Effect on plasma volume calculated from the change in blood hemoglobin

  • Atrial Natriuretic Peptide [ Time Frame: Average over 1 hour ] [ Designated as safety issue: No ]
    Effect on atrial natriuretic peptide


Estimated Enrollment: 15
Study Start Date: August 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668277

Contacts
Contact: Katherine Taylor, MD (416)813-7654 ext 2453 katherine.taylor@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Katherine Taylor, MD    (416)813-7654 ext 2453    katherine.taylor@sickkids.ca   
Sub-Investigator: Jens Aage Kolsen Petersen, MD         
Sub-Investigator: Andrew Redington, MD         
Sub-Investigator: Lee Benson, MD         
Principal Investigator: Katherine Taylor, FANZCA         
Hospital For Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Katherine Taylor, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01668277     History of Changes
Other Study ID Numbers: 1000026525
Study First Received: August 8, 2012
Last Updated: May 31, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Pulmonary Hypertensive Crisis
Pediatrics
Hypertonic Saline

Additional relevant MeSH terms:
Hypertensive Encephalopathy
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014