The haemodynamic effect of sildenafil in mechanically ventilated patients with secondary pulmonary hypertension and ensuing right ventricular failure necessitating the administration of dobutamine

The haemodynamic effect of sildenafil in mechanically ventilated patients with secondary pulmonary hypertension and ensuing right ventricular failure necessitating the administration of dobutamine: a non-randomised non-controlled single arm interventional trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35752874

Enrollment

Registered

2010-09-23

Start date

2007-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary pulmonary hypertension, right ventricular failure Circulatory System Pulmonary hypertension

Interventions

The design of the study included measurements of various haemodynamic parameters by means of invasive Swan Ganz method and of various echocardiographic parameters by means of echocardiography in all p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Secondary pulmonary arterial hypertension (PAH) associated with disorders of the respiratory system or hypoxemia (WHO Group III PAH). PAH was documented by the following echocardiographic criteria: 1.1. Increased systolic pulmonary artery pressure greater than 37 mmHg (using the Doppler-derived tricuspid regurgitation velocity) 1.2. Dilatation of the right cardiac chambers 1.3. Hypertrophy of the RV free wall 1.4. Left sided transposition of the interventricular septum and D-shape derangement of the left ventricle 2. Required mechanical ventilation 3. Admitted to the intensive care unit (ICU) from January 2007 to April 2010 4. Decreased cardiac output necessitating the administration of inotropes. Cardiac output was estimated by Doppler echocardiography at the aortic annular plane. 5. Aged 48 - 65 years, either sex

Exclusion criteria

Exclusion criteria: 1. Secondary PAH due to left ventricular (LV) failure, and/or other causes of secondary PAH 2. Patients exhibited, upon admission, acute respiratory distress syndrome (ARDS) and septic shock 3. Hemodynamically unstable, necessitating administration of any other vasoactive medication during the study period

Design outcomes

Primary

Measure	Time frame
Invasive and non-invasive cardiovascular parameters: 1. Cardiac index 2. Right ventricular fractional area change 3. Pulmonary vascular resistance and systemic vascular resistance indices 4. Right and left ventricular stroke work indices All measured at each of the phases.	—

Secondary

Measure	Time frame
1. Measurements of possible improvements in oxygenation and haemodynamic conditions by means of mixed venous oxygen saturation and PO2 to FIO2 ratio 2. Success of weaning from mechanical ventilation All measured at each of the phases.	—

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026