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

NCT01718613 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2018-05-18

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

DRUG

Vasopressin

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

DRUG

Norepinephrine

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Cristiane M Zambolim, MD · Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-03-31
Completion
2018-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718613 on ClinicalTrials.gov