Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: Study protocol for a cluster-randomized, multiple-crossover trial

Trials

Volumn 18, Issue 1, 2017, Pages

  Self, Wesley H ^a   Semler, Matthew W ^b   Wanderer, Jonathan P ^a   Ehrenfeld, Jesse M ^a   Byrne, Daniel W ^a   Wang, Li ^a   Atchison, Leanne ^c   Felbinger, Matthew ^c   Jones, Ian D ^a   Russ, Stephan ^a   Shaw, Andrew D ^a   Bernard, Gordon R ^b   Rice, Todd W ^b  

^a Department of Emergency Medicine ^*  (United States)

^b Division of Allergy   (United States)

^c VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Crystalloid; Emergency department; Intravenous fluids; Pragmatic trial; Renal failure; Saline

Indexed keywords

ACETIC ACID; BICARBONATE; CALCIUM; CHLORIDE; CREATININE; GLUCONIC ACID; LACTIC ACID; MAGNESIUM; POTASSIUM; RINGER LACTATE SOLUTION; SODIUM; SODIUM CHLORIDE; ACETIC ACID PLUS GLUCONATE SODIUM PLUS MAGNESIUM CHLORIDE PLUS POTASSIUM CHLORIDE PLUS SODIUM CHLORIDE; CRYSTALLOID; ELECTROLYTE; ISOTONIC SOLUTION; RINGER'S LACTATE;

ACUTE KIDNEY FAILURE; ADULT; ARTICLE; CLINICAL PROTOCOL; CLUSTER ANALYSIS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CRITICALLY ILL PATIENT; CROSSOVER PROCEDURE; EMERGENCY WARD; FEMALE; HOSPITAL DISCHARGE; HOSPITAL MORTALITY; HUMAN; INTENSIVE CARE UNIT; INTRAVENOUS DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL; RENAL REPLACEMENT THERAPY; SAMPLE SIZE; COMPARATIVE STUDY; FLUID THERAPY; HOSPITAL EMERGENCY SERVICE; LENGTH OF STAY; METHODOLOGY; MORTALITY; PROCEDURES; PROSPECTIVE STUDY; RISK FACTOR; TENNESSEE; TIME FACTOR; TREATMENT OUTCOME;

ACUTE KIDNEY INJURY; CLINICAL PROTOCOLS; CROSS-OVER STUDIES; ELECTROLYTES; EMERGENCY SERVICE, HOSPITAL; FLUID THERAPY; HOSPITAL MORTALITY; HUMANS; INFUSIONS, INTRAVENOUS; ISOTONIC SOLUTIONS; LENGTH OF STAY; PROSPECTIVE STUDIES; RENAL REPLACEMENT THERAPY; RESEARCH DESIGN; RISK FACTORS; SODIUM CHLORIDE; TENNESSEE; TIME FACTORS; TREATMENT OUTCOME;

EID: 85018491877     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-017-1923-6     Document Type: Article

References (26)

1. Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013;369:1243-51.
2. Semler MW, Rice TW. Saline is not the first choice for crystalloid resuscitation fluids. Crit Care Med. 2016;44:1541-4.
3. Young P. Saline is the solution for crystalloid resuscitation. Crit Care Med. 2016;44:1538-40.
4. Shaw AD, Bagshaw SM, Goldstein SL, et al. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012;255:821-9.
5. Yunos NM, Bellomo R, Hegarty C, et al. Association between a chloride liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012;308:1566-72.
6. Yunos NM, Bellomo R, Glassford N, et al. Chloride-liberal vs. chloride restrictive intravenous fluid administration and acute kidney injury: An extended analysis. Intensive Care Med. 2015;41:257-64.
7. Raghunathan K, Shaw A, Nathanson B, et al. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis. Crit Care Med. 2014;42:1585-91.
8. Shaw AD, Raghunathan K, Peyerl FW, et al. Association between intravenous chloride load during resuscitation and in-hospital mortality among patients with SIRS. Intensive Care Med. 2014;40:1897-905.
9. Rochwerg B, Alhazzani W, Sindi A, et al. for the Fluids in Sepsis and Septic Shock Group. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014;161:347-55.
10. Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW. SALT Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in the Intensive Care Unit: The SALT Randomized Trial. Am J Respir Crit Care Med. 2016. [Epub ahead of print] PMID: 27749094.
11. National Institute for Health and Care Excellence (NICE). Intravenous fluid therapy in adults in hospital. December 2013. https://www.nice.org.uk/guidance/cg174. Accessed 24 Oct 2016.
12. Campbell MJ, Walters SJ. How to design, analyse and report cluster randomised trials in medicine and health related research. Chichester: Wiley; 2014.
13. Parienti JJ, Kuss O. Cluster-crossover design: A method for limiting clusters level effect in community-intervention studies. Contemp Clin Trials. 2007;28:316-23.
14. Ware JH, Hamel MB. Pragmatic trials-guides to better patient care? N Engl J Med. 2011;364:1685-7.
15. Standardized Protocol Items: Recommendations for Interventional Trials (SPIRIT). www.spirit-statement.org. Accessed 04 Dec 2016.
16. Lorenzo M, Davis JW, Negin S, Kaups K, Parks S, Brubaker D, Tyroch A. Can Ringer's lactate be used safely with blood transfusions? Am J Surg. 1998;175:308-10.
17. Semler MW, Rice TW, Shaw AD, Siew ED, Self WH, Kumar AB, et al. Identification of major adverse kidney events within the electronic health record. J Med Syst. 2016;40:167.
18. Upchurch CP, Grijalva CG, Russ S, Collins SP, Semler MW, Rice TW, et al. Comparison of etomidate and ketamine for induction during rapid sequence intubation of adult trauma patients. Ann Emerg Med 2017;69:24-33.e2. doi: 10.1016/j.annemergmed.2016.08.009.
19. Schoenfeld DA, Bernard GR. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002;30:1772-7.
20. Kidney Disease: Improving Global Outcomes (KDIGO), Acute Kidney Injury Work Group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int. 2012;2(Suppl):1-138.
21. Palevsky PM, Molitoris BA, Okusa MD, et al. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology. Clin J Am Soc Nephrol. 2012;7:844-50.
22. Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357(21):2189-94.
23. Zavada J, Hoste E, Cartin-Ceba R, et al. A comparison of three methods to estimate baseline creatinine for RIFLE classification. Nephrol Dial Transplant. 2010;25:3911-8.
24. Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA. 2005;294:2228-30.
25. Dellinger RP, Levy MM, Rhodes A, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013;41:580-637.
26. Rothman KJ, Greenland S, Lash TL. Modern epidemiology. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2008.