Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.
Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time. Phase 2 - All remaining subjects received Iloprost as a continuous treatment. The study was designed for an enrollment of 200 subjects and was ended early.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
A 20 mcg dose of Iloprost will be given initially.
Percent Change in Oxygen Saturation (SpO2) From Baseline
Readings were taken from the medical record and the data may not have been present at the exact time frames.
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Percent Change in Oxygen Saturation (SpO2) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Heart Rate From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Heart Rate From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Number of Treatment Failures
Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: 1. Cardiac Index (CI) \>/= 1.8 L/min/m2 2. Administration of \>/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP \</= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2\</= 55% (or \< 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
Time frame: as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Cardiac Output (CO) From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Cardiac Output (CO) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
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