Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): Rationale and design for a multicentre randomised trial

BMJ Open

Volumn 7, Issue 3, 2017, Pages

  Myles, Paul ^a,b   Bellomo, Rinaldo ^b,c,d   Corcoran, Tomas ^e   Forbes, Andrew ^b   Wallace, Sophie ^a,b   Peyton, Philip ^c   Christophi, Chris ^c,d   Story, David ^d   Leslie, Kate ^b,d,f   Serpell, Jonathan ^a,b   McGuinness, Shay ^g   Parke, Rachel ^g  

^a ALFRED HOSPITAL   (Australia)

^b MONASH UNIVERSITY   (Australia)

^c AUSTIN HOSPITAL   (Australia)

^d UNIVERSITY OF MELBOURNE   (Australia)

^e UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^f ROYAL MELBOURNE HOSPITAL   (Australia)

^g AUCKLAND CITY HOSPITAL   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

INFUSION FLUID;

ABDOMINAL SURGERY; AGED; ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DISABILITY; FEASIBILITY STUDY; FLUID THERAPY; FOLLOW UP; FUNCTIONAL STATUS; HUMAN; LIBERAL FLUID THERAPY; MAJOR CLINICAL STUDY; MAJOR SURGERY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; RESTRICTIVE FLUID THERAPY; SURVIVAL; ABDOMEN; ADULT; CLINICAL TRIAL; FEMALE; MALE; METHODOLOGY; MIDDLE AGED; POSTOPERATIVE COMPLICATION; PROCEDURES; SURGERY; TREATMENT OUTCOME; YOUNG ADULT;

ABDOMEN; ADULT; AGED; FEMALE; FLUID THERAPY; HUMANS; MALE; MIDDLE AGED; POSTOPERATIVE COMPLICATIONS; RESEARCH DESIGN; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85014730959     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-015358     Document Type: Article

References (50)

1. Shires T, Williams J, Brown F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg 1961;154:803-10.
2. Arkiliç CF, Taguchi A, Sharma N, et al. Supplemental perioperative fluid administration increases tissue oxygen pressure. Surgery 2003;133:49-55.
3. Mythen MG, Webb AR. The role of gut mucosal hypoperfusion in the pathogenesis of post-operative organ dysfunction. Intensive Care Med 1994;20:203-9.
4. Davies SJ, Wilson RJ. Preoperative optimization of the high-risk surgical patient. Br J Anaesth 2004;93:121-8.
5. Lobo DN, Bostock KA, Neal KR, et al. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: A randomised controlled trial. Lancet 2002;359:1812-18.
6. Tambyraja AL, Sengupta F, MacGregor AB, et al. Patterns and clinical outcomes associated with routine intravenous sodium and fluid administration after colorectal resection. World J Surg 2004;28:1046-51; discussion 51-2.
7. Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest 1999;115:1371-7.
8. Ruttmann TG, James MF, Aronson I. In vivo investigation into the effects of haemodilution with hydroxyethyl starch (200/0.5) and normal saline on coagulation. Br J Anaesth 1998;80:612-16.
9. Ratner AJ, Lysenko ES, Paul MN, et al. Synergistic proinflammatory responses induced by polymicrobial colonization of epithelial surfaces. Proc Natl Acad Sci USA 2005;102:3429-34.
10. Lang K, Boldt J, Suttner S, et al. Colloids versus crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery. Anesth Analg 2001;93:405-9, 3rd contents page.
11. Brandstrup B, Tønnesen H, Beier-Holgersen R, et al. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: A randomized assessor-blinded multicenter trial. Ann Surg 2003;238:641-8.
12. Nisanevich V, Felsenstein I, Almogy G, et al. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology 2005;103:25-32.
13. Kabon B, Akça O, Taguchi A, et al. Supplemental intravenous crystalloid administration does not reduce the risk of surgical wound infection. Anesth Analg 2005;101:1546-53.
14. MacKay G, Fearon K, McConnachie A, et al. Randomized clinical trial of the effect of postoperative intravenous fluid restriction on recovery after elective colorectal surgery. Br J Surg 2006;93:1469-74.
15. Vermeulen H, Hofland J, Legemate DA, et al. Intravenous fluid restriction after major abdominal surgery: A randomized blinded clinical trial. Trials 2009;10:50.
16. Lassen K, Soop M, Nygren J, et al. Consensus review of optimal perioperative care in colorectal surgery: enhanced recovery after surgery (ERAS) group recommendations. Arch Surg 2009;144:961-9.
17. SIGN. Postoperative management in adults. A practical guide to postoperative care for clinical staff. Scottish Intercollegiate Guidelines Network (SIGN), 2004;77.
18. Fischer PE, Nunn AM, Wormer BA, et al. Vasopressor use after initial damage control laparotomy increases risk for anastomotic disruption in the management of destructive colon injuries. Am J Surg 2013;206:900-3.
19. Plurad DS, Talving P, Lam L, et al. Early vasopressor use in critical injury is associated with mortality independent from volume status. J Trauma 2011;71:565-70; discussion 70-2.
20. Rahbari NN, Zimmermann JB, Schmidt T, et al. Meta-Analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg 2009;96:331-41.
21. Corcoran T, Rhodes JE, Clarke S, et al. Oh KM. Perioperative fluid management strategies in major surgery: A stratified meta-Analysis. Anesth Analg 2012;114:640-51.
22. Shulman MA, Myles PS, Chan MT, et al. Measurement of disability-free survival after surgery. Anesthesiology 2015;122:524-36.
23. World Health Organisation. World report on disability. Technical appendix C. http://wwwwhoint/disabilities/world-report/2011/reportpdf 2011:287-94
24. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt) 2013;14:73-156.
25. Rigg JR, Jamrozik K, Myles PS, et al. Epidural anaesthesia and analgesia and outcome of major surgery: A randomised trial. Lancet 2002;359:1276-82.
26. Höbner M, Schäfer M, Demartines N, et al. Impact of restrictive intravenous fluid replacement and combined epidural analgesia on perioperative volume balance and renal function within a fast track program. J Surg Res 2012;173:68-74.
27. Bijker JB, van Klei WA, Kappen TH, et al. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology 2007;107:213-20.
28. Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: The QoR-15. Anesthesiology 2013;118:1332-40.
29. Finfer S, Bellomo R, Boyce N, et al. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004;350:2247-56.
30. Shander A. Emerging risks and outcomes of blood transfusion in surgery. Semin Hematol 2004;41(1 Suppl 1):117-24.
31. Hebert PC, Wells G, Blajchman MA, et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med 1999;340:409-17.
32. Hebert PC, Yetisir E, Martin C, et al. Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases?. Crit Care Med 2001;29:227-34.
33. Scheingraber S, Rehm M, Sehmisch C, et al. Rapid saline infusion produces hyperchloremic acidosis in patients undergoing gynecologic surgery. Anesthesiology 1999;90:1265-70.
34. 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.
35. 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.
36. Prowle JR, Liu YL, Licari E, et al. Oliguria as predictive biomarker of acute kidney injury in critically ill patients. Crit Care 2011;15: R172.
37. Varadhan KK, Lobo DN. A meta-Analysis of randomised controlled trials of intravenous fluid therapy in major elective open abdominal surgery: getting the balance right. Proc Nutr Soc 2010;69:488-98.
38. Boland MR, Noorani A, Varty K, et al. Perioperative fluid restriction in major abdominal surgery: systematic review and meta-Analysis of randomized, clinical trials. World J Surg 2013;37:1193-202.
39. Warrillow SJ, Weinberg L, Parker F, et al. Perioperative fluid prescription, complications and outcomes in major elective open gastrointestinal surgery. Anaesth Intensive Care 2010;38:259-65.
40. Davies SJ, Yates D, Wilson RJT. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg 2011;112:130-8.
41. Bundgaard-Nielsen M, Secher NH, Kehlet H. Liberal vs. restrictive perioperative fluid therapy-A critical assessment of the evidence. Acta Anaesthesiol Scand 2009;53:843-51.
42. Zacharias M, Conlon NP, Herbison GP, et al. Interventions for protecting renal function in the perioperative period. Cochrane Database Syst Rev 2008;(4):CD003590.
43. Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract 2012;120:c179-84.
44. Liu KD, Thompson BT, Ancukiewicz M, et al. Acute kidney injury in patients with acute lung injury: impact of fluid accumulation on classification of acute kidney injury and associated outcomes. Crit Care Med 2011;39:2665-71.
45. Christelis N, Wallace S, Sage CE, et al. An enhanced recovery after surgery program for hip and knee arthroplasty. Med J Aust 2015;202:363-8.
46. Myles PS, Leslie K, Chan MT, et al. The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): A randomised, single-blind trial. Lancet 2014;384:1446-54.
47. Mamidanna R, Burns EM, Bottle A, et al. Reduced risk of medical morbidity and mortality in patients selected for laparoscopic colorectal resection in England: A population-based study. Arch Surg 2012;146:219-27.
48. Monk TG, Saini V, Weldon BC, et al. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg 2005;100:4-10.
49. Myles PS, Peyton P, Silbert B, et al. Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial. BMJ 2011;342:d1491.
50. Myles P, Weitkamp B, Jones K, et al. Validity and reliability of a post-operative quality of recovery score: The QoR-40. Br J Anaesth 2000;84:11-15.