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Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

Information source: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: Vasopressin (Drug); Norepinephrine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Instituto do Cancer do Estado de São Paulo

Official(s) and/or principal investigator(s):
Cristiane M Zambolim, MD, Principal Investigator, Affiliation: Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP

Summary

Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock. The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.

Clinical Details

Official title: Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

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

Primary outcome: 28-day mortality

Secondary outcome:

90-days mortality

Days alive and free of mechanical ventilation

Days alive and free of vasopressors

Days alive and free of renal replacement therapy

Days alive and free of organ failure

Days alive and free of organ failure

Costs

Eligibility

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

Criteria:

Inclusion Criteria:

- Solid neoplasm needing ICU

- Septic Shock according standard criteria

Exclusion Criteria:

- Younger than 18 years;

- Pregnancy;

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

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

- Acute mesenteric ischemia;

- Acute myocardial infarction;

- Cardiogenic shock;

- Current use of vasopressor before randomization

- Expected ICU stay less than 24 hours

- Enrolled in another study;

- Refusal to consent.

Locations and Contacts

Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Sao Paulo/SP 01246000, Brazil
Additional Information

Starting date: November 2012
Last updated: May 18, 2015

Page last updated: August 23, 2015

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