Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial

Trials

Sean M Bagshaw⁴  Matthew A Weir⁶  Karen Pope²  Neill KJ Adhikari³  Ron Wald¹  Orla M Smith⁵ 

[1] Department of Medicine, University of Toronto, 30 Bond Street, Toronto, ON M5B1W8, Canada;Applied Health Research Centre, Li KaShing Knowledge Institute, St. Michael’s Hospital, 30 Bond Street, Toronto, ON M5B1W8, Canada;Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Room D1.08, 2075 Bayview Avenue, Toronto, ON M4N 3M5, Canada;Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 3C1.12 Walter C. Mackenzie Centre, 8440-112 St, Edmonton, NW RILF3 T6G2B7, Canada;Keenan Research Centre, Li KaShing Knowledge Institute, St. Michael’s Hospital, 30 Bond Street, Toronto, ON M5B1W8, Canada;University Hospital, ALL-139A 339 Windermere Road, London, ON N6A 5A5, Canada

关键词: Critical care;    Renal replacement therapy;    Hemodialysis;    Dialysis;    Critical illness;    Acute kidney injury;   

Others  :  1092944
DOI  :  10.1186/1745-6215-14-320

 received in 2013-06-26, accepted in 2013-09-26,  发布年份 2013

【 摘 要 】

Background

Acute kidney injury is a common and devastating complication of critical illness, for which renal replacement therapy is frequently needed to manage severe cases. While a recent systematic review suggested that “earlier” initiation of renal replacement therapy improves survival, completed trials are limited due to small size, single-centre status, and use of variable definitions to define “early” renal replacement therapy initiation.

Methods/design

This is an open-label pilot randomized controlled trial. One hundred critically ill patients with severe acute kidney injury will be randomly allocated 1:1 to receive “accelerated” initiation of renal replacement therapy or “standard” initiation at 12 centers across Canada. In the accelerated arm, participants will have a venous catheter placed and renal replacement therapy will be initiated within 12 hours of fulfilling eligibility. In the standard initiation arm, participants will be monitored over 7 days to identify indications for renal replacement therapy. For participants in the standard arm with persistent acute kidney injury, defined as a serum creatinine not declining >50% from the value at the time of eligibility, the initiation of RRT will be discouraged unless one or more of the following criteria are fulfilled: serum potassium ≥6.0 mmol/L; serum bicarbonate ≤10 mmol/L; severe respiratory failure (PaO₂/FiO₂<200) or persisting acute kidney injury for ≥72 hours after fulfilling eligibility. The inclusion criteria are designed to identify a population of critically ill adults with severe acute kidney injury who are likely to need renal replacement therapy during their hospitalization, but not immediately. The primary outcome is protocol adherence (>90%). Secondary outcomes include measures of feasibility (proportion of eligible patients enrolled in the trial, proportion of enrolled patients followed to 90 days for assessment of vital status and the need for renal replacement therapy) and safety (occurrence of adverse events).

Discussion

The optimal timing of renal replacement therapy initiation in patients with severe acute kidney injury remains uncertain, representing an important knowledge gap and a priority for high-quality research. This pilot trial is necessary to establish protocol feasibility, confirm the safety of participants and obtain estimated events rates for design of a large definitive trial.

Trial registration number

NCT01557361

【 授权许可】

   
2013 Smith et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C: Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA 2005, 294:813-818.
• [2]Bagshaw SM, Laupland KB, Doig CJ, Mortis G, Fick GH, Mucenski M, Godinez-Luna T, Svenson LW, Rosenal T: Prognosis for long-term survival and renal recovery in critically ill patients with severe acute renal failure: a population-based study. Crit Care 2005, 9:R700-R709. BioMed Central Full Text
• [3]Ahlstrom A, Tallgren M, Peltonen S, Rasanen P, Pettila V: Survival and quality of life of patients requiring acute renal replacement therapy. Intensive Care Med 2005, 31:1222-1228.
• [4]Wald R, Quinn RR, Luo J, Li P, Scales DC, Mamdani MM, Ray JG: Chronic dialysis and death among survivors of acute kidney injury requiring dialysis. JAMA 2009, 302:1179-1185.
• [5]Overberger P, Pesacreta M, Palevsky PM: Management of renal replacement therapy in acute kidney injury: a survey of practitioner prescribing practices. Clin J Am SocNephrol 2007, 2:623-630.
• [6]Ricci Z, Ronco C, D’Amico G, De Felice R, Rossi S, Bolgan I, Bonello M, Zamperetti N, Petras D, Salvatori G, Dan M, Piccinni P: Practice patterns in the management of acute renal failure in the critically ill patient: an international survey. Nephrol Dial Transplant 2006, 21:690-696.
• [7]Klarenbach S, Manns B, Pannu N, Clement FM, Wiebe N, Tonelli M: Economic evaluation of continuous renal replacement therapy in acute renal failure. Int J Technol Assess Health Care 2009, 25:331-338.
• [8]Srisawat N, Lawsin L, Uchino S, Bellomo R, Kellum JA: Cost of acute renal replacement therapy in the intensive care unit: results from The Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) study. Crit Care 2010, 14:R46. BioMed Central Full Text
• [9]Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA: A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med 2010, 363:609-619.
• [10]Karvellas CJ, Farhat MR, Sajjad I, Mogensen SS, Leung AA, Wald R, Bagshaw SM: A comparison of early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury: a systematic review and meta-analysis. Crit Care 2011, 15:R72. BioMed Central Full Text
• [11]Bouman CS, Oudemans-Van Straaten HM, Tijssen JG, Zandstra DF, Kesecioglu J: Effects of early high-volume continuous venovenous hemofiltration on survival and recovery of renal function in intensive care patients with acute renal failure: a prospective, randomized trial. Crit Care Med 2002, 30:2205-2211.
• [12]Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Lo S, McArthur C, McGuinness S, Myburgh J, Norton R, Scheinkestel C, Su S: Intensity of continuous renal-replacement therapy in critically ill patients. N Engl J Med 2009, 361:1627-1638.
• [13]Kellum JA, Mehta RL, Levin A, Molitoris BA, Warnock DG, Shah SV, Joannidis M, Ronco C: Development of a clinical research agenda for acute kidney injury using an international, interdisciplinary, three-step modified Delphi process. Clin J Am SocNephrol 2008, 3:887-894.
• [14]Clark E, Wald R, Walsh M, Bagshaw SM: Timing of initiation of renal replacement therapy for acute kidney injury: a survey of nephrologists and intensivists in Canada. Nephrol Dial Transplant 2012, 27:2761-2767.
• [15]Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P: Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet 2005, 365:1231-1238.
• [16]Cruz DN, de Geus HR, Bagshaw SM: Biomarker strategies to predict need for renal replacement therapy in acute kidney injury. Semin Dial 2011, 24:124-131.
• [17]Shapiro NI, Trzeciak S, Hollander JE, Birkhahn R, Otero R, Osborn TM, Moretti E, Nguyen HB, Gunnerson K, Milzman D, Gaieski DF, Goyal M, Cairns CB, Kupfer K, Lee SW, Rivers EP: The diagnostic accuracy of plasma neutrophil gelatinase-associated lipocalin in the prediction of acute kidney injury in emergency department patients with suspected sepsis. Ann Emerg Med 2010, 56:52-59. e51
• [18]Nickolas TL, O’Rourke MJ, Yang J, Sise ME, Canetta PA, Barasch N, Buchen C, Khan F, Mori K, Giglio J, Devarajan P, Barasch J: Sensitivity and specificity of a single emergency department measurement of urinary neutrophil gelatinase-associated lipocalin for diagnosing acute kidney injury. Ann Intern Med 2008, 148:810-819.
• [19]Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A: Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis 2009, 54:1012-1024.
• [20]de Geus HR, Bakker J, Lesaffre EM, le Noble JL: Neutrophil gelatinase-associated lipocalin at ICU admission predicts for acute kidney injury in adult patients. Am J RespirCrit Care Med 2011, 183:907-914.
• [21]Srisawat N, Murugan R, Lee M, Kong L, Carter M, Angus DC, Kellum JA: Plasma neutrophil gelatinase-associated lipocalin predicts recovery from acute kidney injury following community-acquired pneumonia. Kidney Int 2011, 80:545-552.
• [22]Cook DJ, Blythe D, Rischbieth A, Hebert PC, Zytaruk N, Menon K, Erikson S, Fowler R, Heels-Ansdell D, Meade MO: Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers’ experiences, beliefs, and practices. Crit Care Med 2008, 36:2100-2105.
• [23]Disease K, Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group: KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int 2012, 2(Suppl):1-138.
• [24]Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart K, Suter PM, Thijs LG: The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. Intensive Care Med 1996, 22:707-710.
• [25]Palevsky PM, Zhang JH, O’Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P: Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med 2008, 359:7-20.
• [26]Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA: Timing of renal replacement therapy and clinical outcomes in critically ill patients with severe acute kidney injury. J Crit Care 2009, 24:129-140.
• [27]Bagshaw SM, Wald R, Barton J, Burns KE, Friedrich JO, House AA, James MT, Levin A, Moist L, Pannu N, Stollery DE, Walsh MW: Clinical factors associated with initiation of renal replacement therapy in critically ill patients with acute kidney injury-a prospective multicenter observational study. J Crit Care 2012, 27:268-275.
• [28]Gettings LG, Reynolds HN, Scalea T: Outcome in post-traumatic acute renal failure when continuous renal replacement therapy is applied early vs. late. Intensive Care Med 1999, 25:805-813.
• [29]Liu KD, Himmelfarb J, Paganini E, Ikizler TA, Soroko SH, Mehta RL, Chertow GM: Timing of initiation of dialysis in critically ill patients with acute kidney injury. Clin J Am SocNephrol 2006, 1:915-919.
• [30]Seabra VF, Balk EM, Liangos O, Sosa MA, Cendoroglo M, Jaber BL: Timing of renal replacement therapy initiation in acute renal failure: a meta-analysis. Am J Kidney Dis 2008, 52:272-284.
• [31]Clark E, Wald R, Levin A, Bouchard J, Adhikari NK, Hladunewich M, Richardson RM, James MT, Walsh MW, House AA, Moist L, Stollery DE, Burns KE, Friedrich JO, Barton J, Lafrance JP, Pannu N, Bagshaw SM: Timing the initiation of renal replacement therapy for acute kidney injury in Canadian intensive care units: a multicentre observational study. Can J Anaesth 2012, 59:861-870.
• [32]Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA: Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med 2011, 39:259-265.
• [33]Friedrich JO, Wald R, Bagshaw SM, Burns KE, Adhikari NK: Hemofiltration compared to hemodialysis for acute kidney injury: systematic review and meta-analysis. Crit Care 2012, 16:R146. BioMed Central Full Text
• [34]Van Wert R, Friedrich JO, Scales DC, Wald R, Adhikari NK: High-dose renal replacement therapy for acute kidney injury: systematic review and meta-analysis. Crit Care Med 2010, 38:1360-1369.