Condition category
Circulatory System
Date applied
09/09/2010
Date assigned
23/09/2010
Last edited
03/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes