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

NCT01532505 | Unknown DMC

• 1 other identifier: 18511
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hypotension; Poor Peripheral Perfusion

Keywords

cardiopulmonary bypass; Postcardiotomy vasodilatory shock; Microcirculation; Catecholamines; Vasopressin

Outcome Measures

Primary Outcomes (1)

• VOT assessment of microcirculation

  change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients

  day one

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohamed Ismail: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

University Hospital, LHSC

London, Ontario, N6A 5A5, Canada

Location

Related Publications (2)

• 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.

  BACKGROUND

• Papadopoulos G, Sintou E, Siminelakis S, Koletsis E, Baikoussis NG, Apostolakis E. Perioperative infusion of low- dose of vasopressin for prevention and management of vasodilatory vasoplegic syndrome in patients undergoing coronary artery bypass grafting-A double-blind randomized study. J Cardiothorac Surg. 2010 Mar 28;5:17. doi: 10.1186/1749-8090-5-17.

  PMID: 20346182 BACKGROUND

MeSH Terms

Conditions

Hypotension; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• MOHAMED ISMAIL, MD,MSc

  London HSC

  PRINCIPAL INVESTIGATOR

• JOHN MURKIN, MD, FRCPC

  London HSC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 14, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

CA (1)