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Effect of Transfusion on Mortality and Other Adverse Events Among Critically Ill Septic Patients: An Observational Study Using a Marginal Structural Cox Model*

Dupuis, Claire MD1,2; Garrouste-Orgeas, Maité MD3; Bailly, Sébastien PharmD, PhD1; Adrie, Christophe MD4; Goldgran-Toledano, Dany MD, PhD5; Azoulay, Elie MD, PhD6; Ruckly, Stéphane MSc1; Marcotte, Guillaume MD7; Souweine, Bertrand MD, PhD8; Darmon, Michael MD, PhD9; Cohen, Yves MD10; Schwebel, Carole MD, PhD11; Lacave, Guillaume MD, MSc12; Bouadma, Lila MD, PhD1,2; Timsit, Jean-Francois MD, PhD1,2; on behalf of the OUTCOMEREA Study Group

doi: 10.1097/CCM.0000000000002688
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Objectives: RBC transfusion is often required in patients with sepsis. However, adverse events have been associated with RBC transfusion, raising safety concerns. A randomized controlled trial validated the 7 g/dL threshold, but previously transfused patients were excluded. Cohort studies led to conflicting results and did not handle time-dependent covariates and history of treatment. Additional data are thus warranted to guide patient’s management.

Design: To estimate the effect of one or more RBC within 1 day on three major outcomes (mortality, ICU-acquired infections, and severe hypoxemia) at day 30, we used marginal structural models. A trajectory modeling, based on hematocrit evolution pattern, allowed identification of subgroups. Secondary analyses were performed into each of them.

Setting: A prospective French multicenter database.

Patients: Patients with sepsis at admission. Patients with hemorrhagic shock at admission were excluded.

Interventions: None.

Measurements and Main Results: Overall, in our cohort of 6,016 patients, RBC transfusion was not associated with death (hazard ratio, 1.07; 95% CI, 0.88–1.30; p = 0.52). However, RBC transfusion was associated with increased occurrence of ICU-acquired infections (hazard ratio, 2.77; 95% CI, 2.33–3.28; p < 0.01) and of severe hypoxemia (hazard ratio, 1.29; 95% CI, 1.14–1.47; p < 0.01). A protective effect from death by the transfusion was found in the subgroup with the lowest hematocrit level (26 [interquartile range, 24–28]) (hazard ratio, 0.72; 95% CI, 0.55–0.95; p = 0.02).

Conclusions: RBC transfusion did not affect overall mortality in critically ill patients with sepsis. Increased occurrence rate of ICU-acquired infection and severe hypoxemia are expected outcomes from RBC transfusion that need to be weighted with its benefits in selected patients.

1UMR 1137-IAME Team 5–DeSCID: Decision SCiences in Infectious Diseases control and care Inserm/ Univ Paris Diderot, Sorbonne Paris Cité, Paris, France.

2Medical and Infectious Intensive Care Unit, Bichat Claude Bernard University Hospital, AP-HP, Paris, France.

3Medical-Surgical Intensive Care Unit, Saint-Joseph Hospital, Paris, France.

4Medical-Surgical Intensive Care Unit, Delafontaine Hospital, Saint-Denis, France.

5Medical-Surgical Intensive Care Unit, Gonesse Hospital, Gonesse, France.

6Medical Intensive Care Unit, Saint-Louis University Hospital, APHP, Paris, France.

7Intensive care Unit, Edouard Herriot University Hospital, Lyon, France.

8Medical Intensive Care Unit, Clermont-Ferrand University Hospital, Clemont-Ferrand, France.

9Medical Intensive Care Unit, Saint-Etienne University Hospital, Saint-Priest-en-Jarez, France.

10Medical-Surgical Intensive Care Unit, Avicenne University Hospital, APHP, Bobigny, France.

11Medical-Surgical Intensive Care Unit, Grenoble University Hospital, Grenoble Cedex, France.

12Medical-Surgical Intensive Care Unit, André Mignot Hospital, Le Chesnay, France.

*See also p. 2101.

Members of the OUTCOMEREA study group are listed in Appendix 1.

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).

Drs. Dupuis, Bailly, Ruckly, and Timsit designed the study, assisted in data collection and analysis, and drafted and edited the article. Drs. Garrouste-Orgeas, Adrie, Goldgran-Toledano, Azoulay, Marcotte, Souweine, Darmon, Cohen, Schwebel, Lacave, and Bouadma assisted in data collection and edited the article.

Dr. Azoulay’s institution received funding from Fisher & Paykel, Pfizer, and Cubist, and he received funding from Gilead (board member), Alexion (lectures), and Astellas (lectures). The remaining authors have disclosed that they do not have any potential conflicts of interest.

Supported, in part, by the OUTCOMEREA study group.

For information regarding this article, E-mail: jean-francois.timsit@aphp.fr

Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.