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

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ClinicalTrials.gov Identifier: NCT01532505
Recruitment Status : Unknown
Verified February 2012 by Mohamed Ismail, London Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : February 14, 2012
Last Update Posted : February 15, 2012
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Mohamed Ismail, London Health Sciences Centre

Brief Summary:
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 or disease
Hypotension Poor Peripheral Perfusion

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : February 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vasopressin
U.S. FDA Resources




Primary Outcome Measures :
  1. VOT assessment of microcirculation [ Time Frame: day one ]
    change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

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

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