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ISRCTN
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ISRCTN35752874
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ClinicalTrials.gov identifier
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Public title
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The haemodynamic effect of sildenafil in mechanically ventilated patients with secondary pulmonary hypertension and ensuing right ventricular failure necessitating the administration of dobutamine
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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2010/ICU/sildenafil01trial
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Study hypothesis
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We assessed the response of the right ventricular (RV) function following treatment with sildenafil in mechanically ventilated patients with secondary pulmonary hypertension group III according to World Health Organization (WHO) classification, and ensuing RV failure necessitating the administration of dobutamine. We examined whether the administration of sildenafil could acutely alter RV function, thus facilitating weaning from dobutamine and subsequently weaning from mechanical ventilation.
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Lay summary
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Ethics approval
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Institutional Ethics Committee of the General State Hospital of Athens approved on the 1st January 2007
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Study design
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Non-randomised non-controlled single arm interventional trial
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Secondary pulmonary hypertension, right ventricular failure
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2007
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Anticipated end date
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01/04/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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12 patients
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Interventions
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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 phases of the study.
In phase 1 (day 1), dobutabine was infused (5 µg/kg/min) in 12 patients. On day-2, sildenafil was administered (80 mg/day). Thereafter, weaning from dobutamine was attempted (phase 2: days 2 - 15). Patients who tolerated sildenafil and successfully weaned from dobutamine were considered responders and the rest non-responders (sildenafil stopped). In phase 3 (days 16 - 20) weaning from ventilator was attempted. Echocardiographic, haemodynamic and cGMP measurements were conducted repeatedly, at baseline, phase 1, phase 2 and phase 3 of the study.
Total duration of treatment and follow-up = 20 days.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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General State Hospital of Athens (Greece)
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Trial website
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Publications
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Contact name
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Dr
Dimitrios
Karakitsos
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Address
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Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
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City/town
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Athens
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Zip/Postcode
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14127
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Country
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Greece
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Email
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karakitsosdimitrios@gmail.com
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Sponsor
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General State Hospital of Athens (Greece)
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Address
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c/o Andreas Karabinis
Intensive Care Unit
154 Mesogeion Avenue
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City/town
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Athens
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Zip/Postcode
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14127
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Country
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Greece
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Email
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echolabicu@gmail.com
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Date applied
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09/09/2010
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Last edited
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23/09/2010
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Date ISRCTN assigned
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23/09/2010
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