Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients (VANCS II)

Instituto do Cancer do Estado de São Paulo

Status and phase: Completed; Phase 3

Conditions: Septic Shock

Treatments: Drug: Norepinephrine; Drug: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT01718613

NP 1079/17

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

Norepinephrine

Active Comparator group

Treatment:

Drug: Norepinephrine

Vasopressin

Active Comparator group

Treatment:

Drug: Vasopressin