Effects of Saline on Circulation in Children

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01668277
• Collaborator: (none)
• Enrollment: 15
• Locations: 2
• Arms: 3
• Duration (Months): 28
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertensive Crisis	Drug: 7.2% NaCl; Drug: 0.9% NaCl	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Hypertonic Saline on the Pulmonary Circulation in Children
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pulmonary Vascular Resistance Index [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.

2. Systemic Vascular Resistance Index [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.

3. Cardiac Index [Change from Baseline in Cardiac Index after 1 hour]

   Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.

Secondary Outcome Measures

1. Blood Gas [Average over 1 hour]

   Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer

2. Plasma Volume [Average over 1 hour]

   Effect on plasma volume calculated from the change in blood hemoglobin

3. Atrial Natriuretic Peptide [Average over 1 hour]

   Effect on atrial natriuretic peptide

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital For Sick Children	Toronto	Ontario	Canada	M5G 1X8
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT01668277
• Other Study ID Numbers: 1000026525
• First Posted: Aug 20, 2012
• Last Update Posted: Nov 2, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children: Pulmonary Hypertensive Crisis; Pediatrics; Hypertonic Saline
• Additional relevant MeSH terms: Hypertensive Encephalopathy

Study Results

No Results Posted as of Nov 2, 2020