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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Norepinephrine; Drug: Vasopressin

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo/SP
    • Sao Paulo, Sao Paulo/SP, Brazil, 01246000
      • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Norepinephrine	Drug: Norepinephrine; Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
ACTIVE_COMPARATOR: Vasopressin	Drug: Vasopressin; Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Mortality from all causes in 28-day follow-up	28-day from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-days mortality	Mortality from all causes 90 days after randomization	90 days after randomization
Days alive and free of mechanical ventilation	Days alive and free of mechanical ventilation at 28-day follow-up	28 days after randomization
Days alive and free of vasopressors	Days alive and free of any type of vasopressor agent at 28-day follow-up	28 days after randomization
Days alive and free of renal replacement therapy	requirement of dialysis of hemofiltration at 28-day follow-up	28 days after randomization
SOFA score in 24 hours	Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.	24 hours after ICU admission
SOFA score in 96 hours	Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.	96 hours after randomization

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Cristiane M Zambolim, MD, Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP

Publications and helpful links

General Publications

• Hajjar LA, Zambolim C, Belletti A, de Almeida JP, Gordon AC, Oliveira G, Park CHL, Fukushima JT, Rizk SI, Szeles TF, Dos Santos Neto NC, Filho RK, Galas FRBG, Landoni G. Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. Crit Care Med. 2019 Dec;47(12):1743-1750. doi: 10.1097/CCM.0000000000004023.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (ESTIMATE): October 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Hemostatics; Coagulants; Sympathomimetics; Vasoconstrictor Agents; Antidiuretic Agents; Norepinephrine; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: NP 1079/17