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Fluid Management With a Simplified Conservative Protocol for the Acute Respiratory Distress Syndrome*

Grissom, Colin K. MD, FCCM1,2; Hirshberg, Eliotte L. MD, MS1,2,3; Dickerson, Justin B. PhD, MBA, PStat1,4; Brown, Samuel M. MD, MS1,2; Lanspa, Michael J. MD, MS1,2; Liu, Kathleen D. MD5,6; Schoenfeld, David PhD7; Tidswell, Mark MD8; Hite, R. Duncan MD9; Rock, Peter MD, MBA, FCCM10; Miller, Russell R. III MD, MPH1,2; Morris, Alan H. MD1,2

doi: 10.1097/CCM.0000000000000715
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Objectives: In the Fluid and Catheter Treatment Trial (FACTT) of the National Institutes of Health Acute Respiratory Distress Syndrome Network, a conservative fluid protocol (FACTT Conservative) resulted in a lower cumulative fluid balance and better outcomes than a liberal fluid protocol (FACTT Liberal). Subsequent Acute Respiratory Distress Syndrome Network studies used a simplified conservative fluid protocol (FACTT Lite). The objective of this study was to compare the performance of FACTT Lite, FACTT Conservative, and FACTT Liberal protocols.

Design: Retrospective comparison of FACTT Lite, FACTT Conservative, and FACTT Liberal. Primary outcome was cumulative fluid balance over 7 days. Secondary outcomes were 60-day adjusted mortality and ventilator-free days through day 28. Safety outcomes were prevalence of acute kidney injury and new shock.

Setting: ICUs of Acute Respiratory Distress Syndrome Network participating hospitals.

Patients: Five hundred three subjects managed with FACTT Conservative, 497 subjects managed with FACTT Liberal, and 1,124 subjects managed with FACTT Lite.

Interventions: Fluid management by protocol.

Measurements and Main Results: Cumulative fluid balance was 1,918 ± 323 mL in FACTT Lite, –136 ± 491 mL in FACTT Conservative, and 6,992 ± 502 mL in FACTT Liberal (p < 0.001). Mortality was not different between groups (24% in FACTT Lite, 25% in FACTT Conservative and Liberal, p = 0.84). Ventilator-free days in FACTT Lite (14.9 ± 0.3) were equivalent to FACTT Conservative (14.6 ± 0.5) (p = 0.61) and greater than in FACTT Liberal (12.1 ± 0.5, p < 0.001 vs Lite). Acute kidney injury prevalence was 58% in FACTT Lite and 57% in FACTT Conservative (p = 0.72). Prevalence of new shock in FACTT Lite (9%) was lower than in FACTT Conservative (13%) (p = 0.007 vs Lite) and similar to FACTT Liberal (11%) (p = 0.18 vs Lite).

Conclusions: FACTT Lite had a greater cumulative fluid balance than FACTT Conservative but had equivalent clinical and safety outcomes. FACTT Lite is an alternative to FACTT Conservative for fluid management in Acute Respiratory Distress Syndrome.

Supplemental Digital Content is available in the text.

1Division of Critical Care Medicine, Intermountain Medical Center, Murray, UT.

2Division of Pulmonary and Critical Care, Department of Medicine, University of Utah, Salt Lake City, UT.

3Division of Pediatric Critical Care, University of Utah, Salt Lake City, UT.

4College of Pharmacy, University of Utah, Salt Lake City, UT.

5Division of Nephrology, University of California San Francisco, San Francisco, CA.

6Division of Critical Care Medicine, University of California San Francisco, San Francisco, CA.

7Biostatistics Center, Massachusetts General Hospital, Boston, MA.

8Division of Pulmonary and Critical Care Medicine, Baystate Medical Center, Springfield, MA.

9Respiratory Institute, Cleveland Clinic, Cleveland, OH.

10Department of Anesthesiology, University of Maryland, Baltimore, MD.

* See also p. 477.

The members of the National Institutes of Health/National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Network are listed in Appendix 1.

Institutions where this work was performed: Data analysis and article preparation were performed at Intermountain Medical Center, Murray, Utah, with input from coauthors at institutions participating in the National Institutes of Health, National Heart Lung and Blood Institute, Acute Respiratory Distress Syndrome Network (ARDS Network). Primary data collection during prospective clinical trials of the ARDS Network occurred at participating hospitals. Data from the primary ARDS Network studies were obtained from the Clinical Coordinating Center at Massachusetts General Hospital in Boston.

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 the National Institutes of Health, National Heart Lung and Blood Institute, Acute Respiratory Distress Syndrome Network contracts (HHSN268200536171C, HHSN268200536165C, and HHSN268200536179C).

Dr. Grissom lectured for the Society of Critical Care Medicine (honorarium for lecturing at Fundamentals of Critical Care Ultrasound Courses) and received support for article research from the National Institutes of Health (NIH). His institution received grant support from the NIH National Heart Lung and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Network and Prevention and Early Treatment of Acute Lung Injury Network. Dr. Brown received support for article research from the NIH; served as board member for Vecna Technologies (medical advisor to robotics/informatics company); lectured for the Society of Critical Care Medicine (Critical Care Ultrasound courses as faculty/co-chair); received support from SBP World Technologies (Dr. Brown is cofounder of an air pollution mitigation company); and received royalties from Oxford University Press (academic history book). His institution has a patent with Intermountain Healthcare (Dr. Brown assigned a patent-pending airway device to Intermountain) and received grant support from National Institutes of General Medical Sciences (K23 award; K23GM094465) and from the Intermountain Research and Medical Foundation (various investigator-initiated research studies). Dr. Liu served as board member for Astute Biomedical (Clinical Events Adjudication Committee), Complexa (Scientific Advisory Board), and Cytopheryx (Data Safety Monitoring Board); consulted for Chemocentryx and Abbvie; provided expert testimony for the Law Offices of Randy Moore; has stock options with Amgen; received support for travel from the American Thoracic Society and the American Society of Nephrology; received support from Abbott and CMIC (gifts of reagents for biomarker assays); and received support for article research from the NIH. Dr. Liu and her institution received grant support from the NIH. Dr. Schoenfeld received support for article research from the NIH. His institution received grant support from the NHLBI. Dr. Tidswell received support for travel from the NHLBI, received royalties from University California, San Francisco and received support for article research from the NIH. His institution received grant support from the NHLBI. Dr. Hite consulted for the NIH and Cumberland Pharmaceuticals (Safety Monitoring Boards), received grant support from the NIH (studies focused on ARDS, sepsis, and pneumonia), and received support for article research from the NIH. His institution received grant support from the NIH. Dr. Rock received support from Hospira (supplied dexmedetomidine for the Delirium clinical trial), Covidean (supplied bispectral index monitors for the Dexlirium trial), and CAS Medical Systems (supplied tissue oximeter monitors for the Dexlirium trial) and received support for article research from the NIH. His institution received grant support from the NIH (support for ARDS Network trials: Fluid and Catheter Treatment Trial, Statins for Acutely Injured Lungs from Sepsis [SAILS], Early Versus Delayed Enteral Feeding, Albuterol for Treatment of Acute Lung Injury and for support for NIH-sponsored clinical trials: Modifying the Impact of ICU-Induced Neurologic Dysfunction-USA; Dexlirium; and Red Cell Storage Duration Study), support for travel from the NIH, and provision of materials/assistance (for the NIH-sponsored ARDS Network trial called “SAILS,” AstraZeneca supplied study drugs and the resources to measure blood levels of rosuvastatin). Dr. Miller received support for travel. Dr. Morris received support for article research from the NIH. His institution received grant support, support for travel, and provision of assistance/materials from the NIH ARDS Network contract. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: colin.grissom@imail.org

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