Effects of Saline on Circulation in Children

Study Overview
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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.

Official Title
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Effects of Hypertonic Saline on the Pulmonary Circulation in Children

Conditions
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Pulmonary Hypertensive Crisis

Intervention / Treatment
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* Drug: 7.2% NaCl
* Drug: 0.9% NaCl


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 ml/kg 7.2% NaCl<br>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<br> <br> |
| Active Comparator: 3 ml/kg 0.9% NaCl<br>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<br> <br> |
| Active Comparator: 20 ml/kg 0.9% NaCl<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Vascular Resistance Index | Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization. | Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour | 
| Systemic Vascular Resistance Index | Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization. | Change from Baseline in Systemic Vascular Resistance Index after 1 hour | 
| Cardiac Index | Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization. | Change from Baseline in Cardiac Index after 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Gas | Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer | Average over 1 hour | 
| Plasma Volume | Effect on plasma volume calculated from the change in blood hemoglobin | Average over 1 hour | 
| Atrial Natriuretic Peptide | Effect on atrial natriuretic peptide | Average over 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Hypertensive Crisis, Hypertonic Saline, Pediatrics