Effect of Vasopressin on Tissue Oxygen Saturation in Cardiac Surgery Patients During Cardiopulmonary Bypass
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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 |
- 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 |
Stable patients coming from home for elective cardiac surgery are eligible to participate
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| 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 | |
| Principal Investigator: | MOHAMED ISMAIL, MD,MSc | London HSC |
| Study Director: | JOHN MURKIN, MD, FRCPC | London HSC |
More Information
No publications provided
| 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 Vascular Diseases Cardiovascular Diseases Vasopressins Arginine Vasopressin Hemostatics Coagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013