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
Scientific
Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
14127
Greece
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
14127
Greece
Sponsor information
General State Hospital of Athens (Greece)
Hospital/treatment centre
Hospital/treatment centre
c/o Andreas Karabinis
Intensive Care Unit
154 Mesogeion Avenue
Athens
14127
Greece
echolabicu@gmail.com | |
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 |