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Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Shock

Intervention: Vasopressin (Drug); Norepinephrine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Sao Paulo

Overall contact:
Ludhmila Hajjar, MD, PhD, Phone: 55-11-93194401, Email: ludhmila@usp.br

Summary

Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Composite endpoint of major morbidity according to Society of Thoracic Surgery

Secondary outcome:

Hemodynamic effects

occurence of adverse events and safety

Time on mechanical ventilation

Incidence of infecction

Length of ICU and Hospital stay

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- need vasopressor support

Exclusion Criteria:

- younger than 18 years;

- surgery without cardiopulmonary bypass;

- emergency procedure;

- ascending and descending thoracic aortic procedures;

- left ventricular aneurysm resection; enrollment in another study;

- pregnancy;

- neoplasm;

- Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;

- severe hyponatremia (Na<130mEq/L);

- acute mesenteric ischemia;

- acute myocardial infarction;

- cardiogenic shock; and refusal to consent

Locations and Contacts

Ludhmila Hajjar, MD, PhD, Phone: 55-11-93194401, Email: ludhmila@usp.br

Instituto do Coração, São Paulo 05403-000, Brazil; Recruiting
Ludhmila Hajjar, MD, PhD, Phone: 55-11-93194401, Email: ludhmila@usp.br
Additional Information

Starting date: January 2012
Last updated: February 11, 2013

Page last updated: August 23, 2015

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