Trial Information
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
28-day mortality
Outcome Description:
Mortality from all causes in 28-day follow-up
Outcome Time Frame:
28-day from randomization
Safety Issue:
Yes
Principal Investigator
Cristiane M Zambolim, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
91762
NCT ID:
NCT01718613
Start Date:
November 2012
Completion Date:
December 2013
Related Keywords:
- Septic Shock
- Shock
- Shock, Septic