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Lactated Ringer’s Versus 4% Albumin on Lactated Ringer’s in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial

Park, Clarice Hyesuk Lee MD1; de Almeida, Juliano Pinheiro PhD1; de Oliveira, Gisele Queiroz MD1; Rizk, Stéphanie Itala MD1; Fukushima, Julia Tizue MSc1; Nakamura, Rosana Ely MD1; Mourão, Matheus Moraes MD1; Galas, Filomena Regina Barbosa Gomes PhD2; Abdala, Edson PhD3; Pinheiro Freire, Maristela PhD3; Kalil Filho, Roberto PhD4,5; Costa Auler, Jose Otavio Jr PhD2; Nardelli, Pasquale MD6; Martin, Greg S. MD7; Landoni, Giovanni MD6,8; Hajjar, Ludhmila Abrahao PhD1,4,5

doi: 10.1097/CCM.0000000000003900
Online Clinical Investigations
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Objective: To investigate the effects of the administration of 4% albumin on lactated Ringer’s, when compared with lactated Ringer’s alone, in the early phase of sepsis in cancer patients.

Design: Single-center, randomized, double-blind, controlled-parallel trial.

Setting: A tertiary care university cancer hospital.

Patients: Cancer patients with severe sepsis or septic shock.

Interventions: Between October 2014 and December 2016, patients were randomly assigned to receive either bolus of albumin in a lactated Ringer’s solution or lactated Ringer’s solution alone during the first 6 hours of fluid resuscitation after intensive care medicine (ICU) admission. Primary outcome was defined as death from any cause at 7 days. Secondary outcomes were defined as death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay.

Measurements and Main Results: A total of 360 patients were enrolled in the trial. At 7 days, 46 of 180 patients (26%) died in the albumin group and 40 of 180 (22%) died in the lactated Ringer’s group (p = 0.5). At 28 days, 96 of 180 patients (53%) died in the albumin group and 83 of 180 (46%) died in the lactated Ringer’s group (p = 0.2). No significant differences in secondary outcomes were observed.

Conclusions: Adding albumin to early standard resuscitation with lactated Ringer’s in cancer patients with sepsis did not improve 7-day survival.

1Department of Intensive Care, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.

2Division of Anesthesia, Heart Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.

3Department of Infectious Diseases, Cancer Institute, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.

4Department of Cardiopneumology, Heart Institute, Faculty of Medicine, University of Sao Paulo, Brazil.

5Department of Cardiology, Hospital Siriolibanes, Sao Paulo, Brazil.

6Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.

7Division of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, GA.

8Department of Anesthesia and Intensive Care, Vita-Salute San Raffaele University, Milan, Italy.

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).

Supported, in part, by grants from departmental funds only.

Dr. Martin received funding from Grifols. The remaining authors have disclosed that they do not have any potential conflicts of interest.

This work was performed at the Cancer Institute of the University of Sao Paulo, Sao Paulo, Brazil.

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

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