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

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Vasopressin
Norepinephrine
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto do Cancer do Estado de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Norepinephrine

Vasopressin

Arm Description

Outcomes

Primary Outcome Measures

28-day mortality
Mortality from all causes in 28-day follow-up

Secondary Outcome Measures

90-days mortality
Mortality from all causes 90 days after randomization
Days alive and free of mechanical ventilation
Days alive and free of mechanical ventilation at 28-day follow-up
Days alive and free of vasopressors
Days alive and free of any type of vasopressor agent at 28-day follow-up
Days alive and free of renal replacement therapy
requirement of dialysis of hemofiltration at 28-day follow-up
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.
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.

Full Information

First Posted
October 29, 2012
Last Updated
May 16, 2018
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01718613
Brief Title
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Acronym
VANCS II
Official Title
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine
Arm Type
Active Comparator
Arm Title
Vasopressin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
Primary Outcome Measure Information:
Title
28-day mortality
Description
Mortality from all causes in 28-day follow-up
Time Frame
28-day from randomization
Secondary Outcome Measure Information:
Title
90-days mortality
Description
Mortality from all causes 90 days after randomization
Time Frame
90 days after randomization
Title
Days alive and free of mechanical ventilation
Description
Days alive and free of mechanical ventilation at 28-day follow-up
Time Frame
28 days after randomization
Title
Days alive and free of vasopressors
Description
Days alive and free of any type of vasopressor agent at 28-day follow-up
Time Frame
28 days after randomization
Title
Days alive and free of renal replacement therapy
Description
requirement of dialysis of hemofiltration at 28-day follow-up
Time Frame
28 days after randomization
Title
SOFA score in 24 hours
Description
Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.
Time Frame
24 hours after ICU admission
Title
SOFA score in 96 hours
Description
Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.
Time Frame
96 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane M Zambolim, MD
Organizational Affiliation
Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
State/Province
Sao Paulo/SP
ZIP/Postal Code
01246000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31609774
Citation
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.
Results Reference
derived

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

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