This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Cristiane Maciel Zambolim, Instituto do Cancer do Estado de São Paulo.
Recruitment status was:  Active, not 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: May 18, 2015
Last verified: May 2015
October 29, 2012
May 18, 2015
November 2012
March 2014   (Final data collection date for primary outcome measure)
28-day mortality [ Time Frame: 28-day from randomization ]
Mortality from all causes in 28-day follow-up
days alive and free of organ dysfunction [ Time Frame: 28-day from randomization ]
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 ]
    Mortality from all causes 90 days after randomization
  • Days alive and free of mechanical ventilation [ Time Frame: 28 days after randomization ]
    Days alive and free of mechanical ventilation at 28-day follow-up
  • Days alive and free of vasopressors [ Time Frame: 28 days after randomization ]
    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 ]
    requirement of dialysis of hemofiltration at 28-day follow-up
  • Days alive and free of organ failure [ Time Frame: 24 hours after ICU admission ]
    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 ]
    Days alive and free of organ failure according to sequential organ failure assessment (SOFA)
  • Costs [ Time Frame: Hospital discharge ]
90-days mortality [ Time Frame: 90 days ]
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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.
 
Unknown status
250
December 2015
March 2014   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01718613
91762
Not Provided
Not Provided
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
May 2015

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