Effects of Saline on Circulation in Children

Phase 2TerminatedNCT01668277

The Hospital for Sick Children15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pulmonary Hypertensive Crisis

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pulmonary Vascular Resistance Index

Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.

Time frame: 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.

Time frame: 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.

Time frame: Change from Baseline in Cardiac Index after 1 hour

Secondary Outcomes

Blood Gas

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

Time frame: Average over 1 hour

Plasma Volume

Effect on plasma volume calculated from the change in blood hemoglobin

Time frame: Average over 1 hour

Atrial Natriuretic Peptide

Effect on atrial natriuretic peptide

Time frame: Average over 1 hour

Effects of Saline on Circulation in Children

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes