NCT01718613

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-03-01
• Completion: 2018-05-01
• First posted: 2012-10-31
• Last updated: 2018-05-18

Locations

1 site across 1 country: Brazil