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

The VANCS II Randomized Clinical Trial

Hajjar, Ludhmila Abrahão PhD1,2; Zambolim, Cristiane MD1; Belletti, Alessandro MD3; de Almeida, Juliano Pinheiro MD1; Gordon, Anthony C. MD4; Oliveira, Gisele MD1; Park, Clarice Hyesuk Lee MD1; Fukushima, Julia Tizue MSc1; Rizk, Stephanie Itala MD1; Szeles, Tais Felix MD1; dos Santos Neto, Nestor Cordeiro MD1; Filho, Roberto Kalil MD1,2; Galas, Filomena Regina Barbosa Gomes MD1; Landoni, Giovanni MD3,5

doi: 10.1097/CCM.0000000000004023
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Objectives: Previous trials suggest that vasopressin may improve outcomes in patients with vasodilatory shock. The aim of this study was to evaluate whether vasopressin could be superior to norepinephrine to improve outcomes in cancer patients with septic shock.

Design: Single-center, randomized, double-blind clinical trial, and meta-analysis of randomized trials.

Setting: ICU of a tertiary care hospital.

Patients: Two-hundred fifty patients 18 years old or older with cancer and septic shock.

Interventions: Patients were assigned to either vasopressin or norepinephrine as first-line vasopressor therapy. An updated meta-analysis was also conducted including randomized trials published until October 2018.

Measurements and Main Results: The primary outcome was all-cause mortality at 28 days after randomization. Prespecified secondary outcomes included 90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score 24 hours and 96 hours after randomization. We also measure the prevalence of adverse effects in 28 days. A total of 250 patients were randomized. The primary outcome was observed in 71 patients (56.8%) in the vasopressin group and 66 patients (52.8%) in the norepinephrine group (p = 0.52). There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score.

Conclusions: In cancer patients with septic shock, vasopressin as first-line vasopressor therapy was not superior to norepinephrine in reducing 28-day mortality rate.

1Instituto do Cancer, Hospital das Clinicas, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.

2Departamento de Cardiopneumologia, InCor, Faculdade de Medicina de Universidade de São Paulo, São Paulo, Brazil.

3Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.

4Section of Anaesthetics, Pain Medicine and Intensive Care, Faculty of Medicine, Imperial College London, London, United Kingdom.

5Vita-Salute San Raffaele University, Milan, Italy.

The views expressed are those of the author(s) and not necessarily those of the National Health Service, the National Institutes of Health Research, or the Department of Health.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

This trial was performed at the Instituto do Câncer do Estado de São Paulo da Faculdade de Medicina da Universidade de São Paulo.

This study was sponsored by University of São Paulo and supported by departmental funds only.

Dr. Gordon’s institution received funding from the National Institutes of Health Research (NIHR) Research Professorship award (RP-2015-06-018) and the NIHR Comprehensive Biomedical Research Centre based at Imperial College Healthcare National Health Service Trust and Imperial College London, and, outside of the submitted work, he has received speaker fees from Orion Corporation, Orion Pharma, and Amomed Pharma. He has consulted for Ferring Pharmaceuticals, Tenax Therapeutics, Baxter Healthcare, Bristol-Myers Squibb, and GlaxoSmithKline, and received grant support from Orion Corporation, Orion Pharma, Tenax Therapeutics, and Hospital Corporation of America International with funds paid to his institution. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Trial registration number: ClinicalTrials.gov NCT01718613.

For information regarding this article, E-mail: landoni.giovanni@hsr.it

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