Liberal Versus Restrictive Intravenous Fluid Therapy for Early Septic Shock: Rationale for a Randomized Trial - 19/09/18
, Matthew W. Semler, MD, MSc a, Rinaldo Bellomo, MBBS, MD b, Samuel M. Brown, MD, MS c, Bennett P. deBoisblanc, MD d, Matthew C. Exline, MD e, Adit A. Ginde, MD, MPH f, Colin K. Grissom, MD c, David R. Janz, MD, MSc d, Alan E. Jones, MD g, Kathleen D. Liu, MD h, Stephen P.J. Macdonald, MB, ChB i, Chadwick D. Miller, MD, MS j, Pauline K. Park, MD k, Lora A. Reineck, MD, MS l, Todd W. Rice, MD, MSc a, Jay S. Steingrub, MD m, Daniel Talmor, MD n, Donald M. Yealy, MD o, Ivor S. Douglas, MD p, Nathan I. Shapiro, MD, MPH nand the
CLOVERS Protocol Committee and NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network Investigators†
Abstract |
Prompt intravenous fluid therapy is a fundamental treatment for patients with septic shock. However, the optimal approach for administering intravenous fluid in septic shock resuscitation is unknown. Two competing strategies are emerging: a liberal fluids approach, consisting of a larger volume of initial fluid (50 to 75 mL/kg [4 to 6 L in an 80-kg adult] during the first 6 hours) and later use of vasopressors, versus a restrictive fluids approach, consisting of a smaller volume of initial fluid (≤30 mL/kg [≤2 to 3 L]), with earlier reliance on vasopressor infusions to maintain blood pressure and perfusion. Early fluid therapy may enhance or maintain tissue perfusion by increasing venous return and cardiac output. However, fluid administration may also have deleterious effects by causing edema within vital organs, leading to organ dysfunction and impairment of oxygen delivery. Conversely, a restrictive fluids approach primarily relies on vasopressors to reverse hypotension and maintain perfusion while limiting the administration of fluid. Both strategies have some evidence to support their use but lack robust data to confirm the benefit of one strategy over the other, creating clinical and scientific equipoise. As part of the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network, we designed a randomized clinical trial to compare the liberal and restrictive fluids strategies, the Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis trial. The purpose of this article is to review the current literature on approaches to early fluid resuscitation in adults with septic shock and outline the rationale for the upcoming trial.
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| Supervising editor: David A. Talan, MD |
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| Authorship: All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). This work was supported by National Heart, Lung, and Blood Institute U01 grants HL123009, HL123010, HL123004, HL123022, HL122989, HL123008, HL123027, HL123020, HL123018, HL123031, HL123033, HL122998, and HL123023. Dr. Self was supported in part by K23GM110469 from the National Institute of General Medical Sciences. All authors are supported by the National Heart, Lung, and Blood Institute within the National Institutes of Health (NIH) for participation in the Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network. Dr. Self reports receiving grants from Cheetah Medical; consultant fees from Abbott Point of Care, Cempra Pharmaceuticals, Ferring Pharmaceuticals, and BioTest AG; and travel funds from Gilead Sciences and Pfizer. Dr. Brown reports receiving fees from Faron Pharmaceuticals for serving on a steering committee for a clinical trial in acute respiratory distress syndrome. Dr. Ginde reports receiving consulting fees from the Coalition for Sepsis Survival (a nonprofit foundation) to develop sepsis-related algorithms. Dr. Liu reports stock ownership with Amgen; receiving consultant fees from Achaogen, Durect, Z S Pharma, Theravance, Quark, and Potrero Medical; receiving travel funds from the American Society of Nephrology and National Policy Forum on Critical Care and Acute Renal Failure; and receiving compensation for an editorial position from the National Kidney Foundation. Dr. Miller reports receiving grants from Abbott, Ferring, Siemens, as well as software from Siemens. Dr. Rice reports receiving consultant fees from Cumberland Pharmaceuticals, Inc, and personal fees from Avisa Pharma, LLC. Dr. Douglas reports a relationship with Cheetah Medical in which he is principal investigator for an industry-sponsored sepsis trial; payments for his principal investigator role and study-site enrollment are to his employer, an academic hospital. Dr. Shapiro reports receiving research funding from the NIH, Siemens, Lajolla Pharmaceuticals, and ThermoFisher, as well as advisory board income from Baxter. |
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| Trial registration number: NCT03434028 |
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| The opinions expressed in this article are those of the authors and do not necessarily represent those of the US Department of Health and Human Services, the National Institutes of Health, or the National Heart, Lung, and Blood Institute. |
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Vol 72 - N° 4
P. 457-466 - octobre 2018 Retour au numéro
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