Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients (VANCS II)
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|ClinicalTrials.gov Identifier: NCT01718613|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : May 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Vasopressin Drug: Norepinephrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||May 2018|
|Active Comparator: Norepinephrine||
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
|Active Comparator: Vasopressin||
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
- 28-day mortality [ Time Frame: 28-day from randomization ]Mortality from all causes in 28-day follow-up
- 90-days mortality [ Time Frame: 90 days after randomization ]Mortality from all causes 90 days after randomization
- Days alive and free of mechanical ventilation [ Time Frame: 28 days after randomization ]Days alive and free of mechanical ventilation at 28-day follow-up
- Days alive and free of vasopressors [ Time Frame: 28 days after randomization ]Days alive and free of any type of vasopressor agent at 28-day follow-up
- Days alive and free of renal replacement therapy [ Time Frame: 28 days after randomization ]requirement of dialysis of hemofiltration at 28-day follow-up
- SOFA score in 24 hours [ Time Frame: 24 hours after ICU admission ]Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.
- SOFA score in 96 hours [ Time Frame: 96 hours after randomization ]Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718613
|Instituto do Cancer do Estado de Sao Paulo|
|Sao Paulo, Sao Paulo/SP, Brazil, 01246000|
|Principal Investigator:||Cristiane M Zambolim, MD||Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP|