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

Septic Shock Clinical Trial

— VANCS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718613
• Other study ID #: NP 1079/17
• Status: Completed
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2018
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo	Sao Paulo	Sao Paulo/SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	Mortality from all causes in 28-day follow-up	28-day from randomization
Secondary	90-days mortality	Mortality from all causes 90 days after randomization	90 days after randomization
Secondary	Days alive and free of mechanical ventilation	Days alive and free of mechanical ventilation at 28-day follow-up	28 days after randomization
Secondary	Days alive and free of vasopressors	Days alive and free of any type of vasopressor agent at 28-day follow-up	28 days after randomization
Secondary	Days alive and free of renal replacement therapy	requirement of dialysis of hemofiltration at 28-day follow-up	28 days after randomization
Secondary	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.	24 hours after ICU admission
Secondary	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.	96 hours after randomization