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

Study Overview
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Brief Summary
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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.

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Vasopressin
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Norepinephrine<br> | Drug: Norepinephrine<br>* Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement<br>|
| Active Comparator: Vasopressin<br> | Drug: Vasopressin<br>* Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Mortality from all causes in 28-day follow-up | 28-day from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days mortality | Mortality from all causes 90 days after randomization | 90 days after randomization | 
| Days alive and free of mechanical ventilation | Days alive and free of mechanical ventilation at 28-day follow-up | 28 days after randomization | 
| 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 | 
| Days alive and free of renal replacement therapy | requirement of dialysis of hemofiltration at 28-day follow-up | 28 days after randomization | 
| 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 | 
| 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 |