Effects of Saline on Circulation in Children
This study is not yet open for participant recruitment.
Verified August 2012 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01668277
First received: August 8, 2012
Last updated: August 14, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2012 (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 | Not yet 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 | |
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: | 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: | August 14, 2012 |
| 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 May 22, 2013