Effect of Vasopressin on Tissue Oxygen Saturation in Cardiac Surgery Patients During Cardiopulmonary Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by London Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Mohamed Ismail, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01532505
First received: January 19, 2012
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

The objective of this research is to compare the effect of a low dose Vasopressin infusion or placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and tissue oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in elective on pump cardiac surgery patients using a non-invasive near infrared spectrometry (NIRS) machine. The clinical implications are that NIRS may permit earlier, non-invasive detection of significant physiologic derangements and allow more accurate and timely titration of medications, fluids and surgical intervention. The use of a low dose vasopressin seems to be preventive for the incidence of observed post-cardiotomy vasodilatory shock and may improve the function of microcirculation that will be assessed using VOT and tNIRS. Finally, it may decrease both catecholamine dose and duration of their administration, it is considered as a useful agent for decreasing all heir side-effects


Condition
Hypotension
Poor Peripheral Perfusion

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized Study Comparing Low Dose Vasopressin Infusion or Placebo on Near Infrared Spectroscopy Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients During Cardiopulmonary Bypass: A Pilot Study

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • VOT assessment of microcirculation [ Time Frame: day one ] [ Designated as safety issue: No ]
    change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Stable patients coming from home for elective cardiac surgery are eligible to participate

Criteria

Inclusion Criteria:

  • Adult, elective cardiac surgery patients with the use of cardiopulmonary bypass (CPB)

Exclusion Criteria:

  • Age less than 18 years
  • Contraindication to pneumatic cuff inflation (arteriovenous fistula, previous mastectomy, injury to arm)
  • Pregnancy
  • Significant peripheral vascular disease of the arms*
  • Emergency surgery
  • Uncured cancer during chemotherapy
  • Lack of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532505

Locations
Canada, Ontario
University Hospital, LHSC Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Mohamed Ismail, MD, MSc    (519) 494-5133    Mohamed.Ismail@londonhospitals.ca   
Sponsors and Collaborators
Mohamed Ismail
London Health Sciences Centre
Investigators
Principal Investigator: MOHAMED ISMAIL, MD,MSc London HSC
Study Director: JOHN MURKIN, MD, FRCPC London HSC
  More Information

Publications:
Peripheral Tissue Oxygen Saturation (SaO2) Monitoring and the Vascular Occlusion Test in Cardiac Surgery: A Pilot Study. Smith R, Murkin J, Granton J, Guo LR, McKenzie FN, Min F, Zhang R. ASA Chicago, Oct 15-19, 2011, Anesthesiology 2011 A278.

Responsible Party: Mohamed Ismail, Principal investigator, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01532505     History of Changes
Other Study ID Numbers: 18511
Study First Received: January 19, 2012
Last Updated: February 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by London Health Sciences Centre:
cardiopulmonary bypass
Postcardiotomy vasodilatory shock
Microcirculation
Catecholamines
Vasopressin

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Arginine Vasopressin
Vasopressins
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 22, 2014