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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Information provided by (Responsible Party):
Cristiane Maciel Zambolim, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01718613
First received: October 29, 2012
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Septic Shock
Drug: Vasopressin
Drug: Norepinephrine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • 28-day mortality [ Time Frame: 28-day from randomization ] [ Designated as safety issue: Yes ]
    Mortality from all causes in 28-day follow-up


Secondary Outcome Measures:
  • 90-days mortality [ Time Frame: 90 days after randomization ] [ Designated as safety issue: Yes ]
    Mortality from all causes 90 days after randomization

  • Days alive and free of mechanical ventilation [ Time Frame: 28 days after randomization ] [ Designated as safety issue: Yes ]
    Days alive and free of mechanical ventilation at 28-day follow-up

  • Days alive and free of vasopressors [ Time Frame: 28 days after randomization ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    requirement of dialysis of hemofiltration at 28-day follow-up

  • Days alive and free of organ failure [ Time Frame: 24 hours after ICU admission ] [ Designated as safety issue: Yes ]
    Days alive and free of organ failure according the sequential organ failure assessment (SOFA)

  • Days alive and free of organ failure [ Time Frame: 96 hours after randomization ] [ Designated as safety issue: Yes ]
    Days alive and free of organ failure according to sequential organ failure assessment (SOFA)

  • Costs [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718613

Contacts
Contact: Cristiane M Zambolim, MD +11-55-3893-3267 czambolim@yahoo.com.br
Contact: Ludhmila A Hajjar, MD, PhD +11-55-3893-3267 ludhmila@usp.br

Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo Recruiting
Sao Paulo, Sao Paulo/SP, Brazil, 01246000
Contact: Cristiane M Zambolim, MD    +55-11-38933267    czambolim@yahoo.com.br   
Principal Investigator: Cristiane M Zambolim, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Cristiane Maciel Zambolim, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01718613     History of Changes
Other Study ID Numbers: 91762
Study First Received: October 29, 2012
Last Updated: November 2, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Shock
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Arginine Vasopressin
Norepinephrine
Vasopressins
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Antidiuretic Agents
Autonomic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 21, 2014