Pulmonary Hypertensive Crisis
Conditions
Keywords
Pulmonary Hypertensive Crisis, Pediatrics, Hypertonic Saline
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.
Interventions
DRUG0.9% NaCl
DRUG7.2% NaCl
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Cardiac Index | Change from Baseline in Cardiac Index after 1 hour | Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Gas | Average over 1 hour | Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer |
| Plasma Volume | Average over 1 hour | Effect on plasma volume calculated from the change in blood hemoglobin |
| Atrial Natriuretic Peptide | Average over 1 hour | Effect on atrial natriuretic peptide |
Countries
Canada
Outcome results
None listed