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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine | Active Comparator |
| |
| Vasopressin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin | Drug | Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | Mortality from all causes in 28-day follow-up | 28-day from randomization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane M Zambolim, MD | Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de Sao Paulo | São Paulo | Sao Paulo/SP | 01246000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31609774 | Derived | Hajjar LA, Zambolim C, Belletti A, de Almeida JP, Gordon AC, Oliveira G, Park CHL, Fukushima JT, Rizk SI, Szeles TF, Dos Santos Neto NC, Filho RK, Galas FRBG, Landoni G. Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. Crit Care Med. 2019 Dec;47(12):1743-1750. doi: 10.1097/CCM.0000000000004023. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Norepinephrine | Drug | Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement |
|
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |