Contact information
Type
Scientific
Primary contact
Dr Dimitrios Karakitsos
ORCID ID
Contact details
Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
14127
Greece
karakitsosdimitrios@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2010/ICU/sildenafil01trial
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
Institutional Ethics Committee of the General State Hospital of Athens approved on the 1st January 2007
Study design
Non-randomised non-controlled single arm interventional trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Secondary pulmonary hypertension, right ventricular failure
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Sildenafil
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/01/2007
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 patients
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Greece
Trial participating centre
Intensive Care Unit
Athens
14127
Greece
Sponsor information
Organisation
General State Hospital of Athens (Greece)
Sponsor details
c/o Andreas Karabinis
Intensive Care Unit
154 Mesogeion Avenue
Athens
14127
Greece
echolabicu@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
General State Hospital of Athens (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22386699
Publication citations
-
Results
Karakitsos D, Papanikolaou J, Karabinis A, Alalawi R, Wachtel M, Jumper C, Alexopoulos D, Davlouros P, Acute effect of sildenafil on central hemodynamics in mechanically ventilated patients with WHO group III pulmonary hypertension and right ventricular failure necessitating administration of dobutamine., Int. J. Cardiol., 2013, 167, 3, 848-854, doi: 10.1016/j.ijcard.2012.02.006.