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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Instituto do Cancer do Estado de São Paulo.
Recruitment status was  Recruiting
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

October 29, 2012
November 2, 2012
November 2012
November 2013   (final data collection date for primary outcome measure)
28-day mortality [ Time Frame: 28-day from randomization ] [ Designated as safety issue: Yes ]
Mortality from all causes in 28-day follow-up
days alive and free of organ dysfunction [ Time Frame: 28-day from randomization ] [ Designated as safety issue: Yes ]
days alive and free of organ dysfunction during the first 28 days according to the sequential organ failure assessement
Complete list of historical versions of study NCT01718613 on ClinicalTrials.gov Archive Site
  • 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 ]
90-days Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
90-day mortality from randomization
Not Provided
Not Provided
 
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Septic Shock
  • Drug: Vasopressin
    Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
  • Drug: Norepinephrine
    Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
  • Active Comparator: Norepinephrine
    Intervention: Drug: Norepinephrine
  • Active Comparator: Vasopressin
    Intervention: Drug: Vasopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Brazil
 
NCT01718613
91762
Not Provided
Cristiane Maciel Zambolim, Instituto do Cancer do Estado de São Paulo
Instituto do Cancer do Estado de São Paulo
Not Provided
Principal Investigator: Cristiane M Zambolim, MD Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
Instituto do Cancer do Estado de São Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP