Overview

This trial is active, not recruiting.

Condition septic shock
Treatments vasopressin, norepinephrine
Phase phase 3
Sponsor Instituto do Cancer do Estado de São Paulo
Start date November 2012
End date March 2014
Trial size 250 participants
Trial identifier NCT01718613, 91762

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
norepinephrine
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
(Active Comparator)
vasopressin
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement

Primary Outcomes

Measure
28-day mortality
time frame: 28-day from randomization

Secondary Outcomes

Measure
90-days mortality
time frame: 90 days after randomization
Days alive and free of mechanical ventilation
time frame: 28 days after randomization
Days alive and free of vasopressors
time frame: 28 days after randomization
Days alive and free of renal replacement therapy
time frame: 28 days after randomization
Days alive and free of organ failure
time frame: 24 hours after ICU admission
Days alive and free of organ failure
time frame: 96 hours after randomization
Costs
time frame: Hospital discharge

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Principal investigator Cristiane M Zambolim, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Instituto do Cancer do Estado de São Paulo.