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OpenTrials
Completed

NCT Number: NCT01718613

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto do Cancer do Estado de Sao Paulo

São Paulo, Sao Paulo/SP, 01246000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vasopressin

Drug

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement

norepinephrine

Drug

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement

Primary outcomes

  1. 28-day mortality

    Time frame: 28-day from randomization

    Mortality from all causes in 28-day follow-up

Secondary outcomes

  1. 90-days mortality

    Time frame: 90 days after randomization

    Mortality from all causes 90 days after randomization

  2. 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

  3. 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

  4. Days alive and free of renal replacement therapy

    Time frame: 28 days after randomization

    requirement of dialysis of hemofiltration at 28-day follow-up

  5. SOFA score in 24 hours

    Time frame: 24 hours after ICU admission

    Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization.

  6. SOFA score in 96 hours

    Time frame: 96 hours after randomization

    Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Acronym: VANCS II

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Oct 31, 2012
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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