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

Phase 3

Completed

• Conditions: Septic Shock
• Interventions: Drug: Norepinephrine; Drug: Vasopressin

• Registration Number: NCT01718613
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Study Start: 2012-11
• Primary Completion: 2014-03
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norepinephrine	Norepinephrine	-
Vasopressin	Vasopressin	-

Primary Outcome Measures

Name	Time	Method
28-day mortality	28-day from randomization	Mortality from all causes in 28-day follow-up

Secondary Outcome Measures

Name	Time	Method
90-days mortality	90 days after randomization	Mortality from all causes 90 days after randomization
Days alive and free of mechanical ventilation	28 days after randomization	Days alive and free of mechanical ventilation at 28-day follow-up
Days alive and free of vasopressors	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	28 days after randomization	requirement of dialysis of hemofiltration at 28-day follow-up
SOFA score in 24 hours	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.
SOFA score in 96 hours	96 hours after randomization	Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization.

Trial Locations

Locations (1)

Instituto do Cancer do Estado de Sao Paulo; 🇧🇷 Sao Paulo, Sao Paulo/SP, Brazil