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Effects of Saline on Circulation in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668277
First Posted: August 20, 2012
Last Update Posted: December 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katherine Taylor, The Hospital for Sick Children
  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 (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Hypertonic Saline on the Pulmonary Circulation in Children

Further study details as provided by Katherine Taylor, 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 ]
    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 ]
    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 ]
    Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.


Secondary Outcome Measures:
  • Blood Gas [ Time Frame: Average over 1 hour ]
    Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer

  • Plasma Volume [ Time Frame: Average over 1 hour ]
    Effect on plasma volume calculated from the change in blood hemoglobin

  • Atrial Natriuretic Peptide [ Time Frame: Average over 1 hour ]
    Effect on atrial natriuretic peptide


Enrollment: 15
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668277


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

Responsible Party: Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01668277     History of Changes
Other Study ID Numbers: 1000026525
First Submitted: August 8, 2012
First Posted: August 20, 2012
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Katherine Taylor, 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