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

ISRCTN	ISRCTN35752874
DOI	https://doi.org/10.1186/ISRCTN35752874
Secondary identifying numbers	2010/ICU/sildenafil01trial

Submission date: 09/09/2010
Registration date: 23/09/2010
Last edited: 03/04/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dimitrios Karakitsos
Scientific

Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
14127
Greece

Email	karakitsosdimitrios@gmail.com

Study information

Study design	Non-randomised non-controlled single arm interventional trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Institutional Ethics Committee of the General State Hospital of Athens approved on the 1st January 2007
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sildenafil
Primary outcome measure	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 study start date	01/01/2007
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	12 patients
Key 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
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

Greece

Study participating centre

Intensive Care Unit

Athens
14127
Greece

Sponsor information

General State Hospital of Athens (Greece)
Hospital/treatment centre

c/o Andreas Karabinis
Intensive Care Unit
154 Mesogeion Avenue
Athens
14127
Greece

Email	echolabicu@gmail.com
"ROR"	https://ror.org/00zq17821

Funders

Funder type

Hospital/treatment centre

General State Hospital of Athens (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/08/2013		Yes	No