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Status:

COMPLETED

Does Oral Sildenafil (Viagra) Decrease Mean Pulmonary Artery Pressure After Cardiac Surgery?

Lead Sponsor:

Unity Health Toronto

Collaborating Sponsors:

University of Toronto

Conditions:

Pulmonary Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery. Several treatm...

Detailed Description

Sildenafil citarte is a selective pulmonary vasodilator without profound effects on systemic hemodynamics making it an attractive option for treating post operative pulmonary hypertension in the cardi...

Eligibility Criteria

Inclusion

  • 18 years of age or older
  • Scheduled for or has recently undergone a primary or re-do cardiac surgical procedure including coronary artery bypass graft surgery (CABG), heart valve replacement or repair, ascending aortic replacement or repair or any combinations of these procedures with CPB
  • No documented allergy to sildenafil citrate
  • No clinical or laboratory evidence on routine blood work of significant renal disease or failure. (requires dialysis or a creatinine \>/= 200umol/L)
  • No clinical or documented laboratory evidence on routine blood work of hepatic disease or failure. (ALT or AST 5x upper limit of normal (ULN) or jaundice)
  • The patient if female and of child bearing age is not known to be pregnant.
  • No documented history of severe chronic respiratory disease defined as an FEV/VC1\< 50% predicted.
  • Not currently enrolled as an active participant in another clinical trial of a medical therapy or device.
  • No documented stroke or transient ischemic attack within 6 months of study participation
  • No documented critical carotid artery stenosis (\>70%)
  • No retinitis pigmentosa.
  • The patient has authorized his/her consent to participate in this trial pre-operatively OR consent to participation is granted on the patient's behalf by a substitute decision maker pre or post operatively.
  • POST-OPERATIVELY
  • A pulmonary arterial catheter (swan-ganz catheter) is insitu.
  • The patient has a mPAP measurement of \>/= 25mmHg for at least 1 hour.
  • The patient has a mean arterial pressure (MAP) of \>/= 65mmHg.
  • The patient has a heart rate of greater than 40 and less than 130 beats/minute.
  • The patient is intubated and mechanically ventilated as per standard ventilation protocol at St. Michael's Hospital.
  • The patient has not received intravenous nitroglycerin or nitroprusside within 1 hour before treatment with study medication.

Exclusion

  • POST-OPERATIVELY
  • The patient requires nitroglycerin based medications continuously (topical/oral/intravenous)
  • The patient has an arterial pH of \< 7.30 or ≥ 7.47
  • The patient has clinical and or documented laboratory evidence from routine blood work of renal dysfunction or failure. (Doubling of pre-operative creatinine or requiring dialysis is indicative of renal dysfunction.)
  • The patient has clinical and or documented laboratory evidence from routine blood work of significant hepatic disease or failure. (ALT or AST 5 times ULN or obvious jaundice will be indicative of liver dysfunction)
  • The patient's current medical condition in the opinion of the investigator and/or the patient's attending ICU physician makes him/her inappropriate for participation in this study.
  • The patient is currently a participant in a clinical trial of an investigational therapy including a drug or medical device.
  • The patient has clinical indications of sepsis defined as 2 of the following five criteria: i) leukocytosis (or) leukopenia: wbc \>12 x 109/L (or) \<4x109/L (\>10% bands also, ii) fever (or) hypothermia (temp \>38.5C or \<36C), iii) tachycardia, hr \> 90 beats/minute, iv) tachypnea, respiratory rate (RR) \>18 breaths/minute, v) hypotension, SBP \<90 mmHg

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2009

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00334490

Start Date

March 1 2005

End Date

May 1 2009

Last Update

July 31 2015

Active Locations (1)

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1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8