Hypothermia During Partial Nephrectomy for Patients with Renal Tumors: A Randomized Controlled Trial

No AccessJournal of UrologyAdult Urology1 May 2021Hypothermia During Partial Nephrectomy for Patients with Renal Tumors: A Randomized Controlled Trial Rodney H. Breau, Dean A. Fergusson, Greg Knoll, Kristen McAlpine, Christopher Morash, Sonya Cnossen, Luke T. Lavallée, Ranjeeta Mallick, Antonio Finelli, Michael A. S. Jewett, Bradley C. Leibovich, Jonathan A. Cook, Anil Kapoor, Frederic Pouliot, Jonathan Izawa, Ricardo Rendon, and Ilias Cagiannos Rodney H. BreauRodney H. Breau *Correspondence: Ottawa Hospital Research Institute, Division of Urology, The University of Ottawa, General Campus, 501 Smyth Rd. Box 222, Ottawa, Ontario K1H 8L6, Canada telephone: 613-737-8899; ext. 73019; E-mail Address: [email protected] Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada , Dean A. FergussonDean A. Fergusson Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada , Greg KnollGreg Knoll Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada Division of Nephrology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada , Kristen McAlpineKristen McAlpine Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada , Christopher MorashChristopher Morash Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada , Sonya CnossenSonya Cnossen Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada , Luke T. LavalléeLuke T. Lavallée Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada , Ranjeeta MallickRanjeeta Mallick Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada , Antonio FinelliAntonio Finelli Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto, Ontario, Canada , Michael A. S. JewettMichael A. S. Jewett Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto, Ontario, Canada , Bradley C. LeibovichBradley C. Leibovich Department of Urology, Mayo Clinic, Rochester, Minnesota , Jonathan A. CookJonathan A. Cook Oxford Clinical Trial Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK , Anil KapoorAnil Kapoor Division of Urology, McMaster University, Hamilton, Ontario, Canada , Frederic PouliotFrederic Pouliot Division of Urology, Université Laval, Quebec City, Québec, Canada , Jonathan IzawaJonathan Izawa Division of Urology, Department of Surgery, Western University, London, Ontario, Canada , Ricardo RendonRicardo Rendon Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada , and Ilias CagiannosIlias Cagiannos Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada View All Author Informationhttps://doi.org/10.1097/JU.0000000000001517AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. Materials and Methods: We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m2 at a 5% significance level. Results: Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was −6.6 ml/minute/1.73 m2 in the hypothermia group and −7.8 ml/minute/1.73 m2 in the control group (mean difference 1.2 ml/minute/1.73 m2, 95% CI −3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (−5.8 vs −6.3 ml/minute/1.73 m2; mean difference 0.5 ml/minute/1.73 m2, 95% CI −2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life. Conclusions: Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function. References 1. : Partial nephrectomy: technique, complications and pathological findings. J Urol 1995; 154: 1312. Link, Google Scholar 2. : Ischemia techniques in nephron-sparing surgery: a systematic review and meta-analysis of surgical, oncological, and functional outcomes. Eur Urol 2019; 75: 477. Google Scholar 3. : Tolerance of the human kidney to isolated controlled ischemia. J Am Soc Nephrol 2013; 24: 506. Google Scholar 4. : Renal ischemia/reperfusion injury; from pathophysiology to treatment. J Ren Inj Prev 2015; 4: 20. Google Scholar 5. : Ischemia and functional recovery from partial nephrectomy: refined perspectives. Eur Urol Focus 2018; 4: 572. 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Google Scholar Supported by the Canadian Institute of Health Research. © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited BySmith J (2021) This Month in Adult UrologyJournal of Urology, VOL. 205, NO. 5, (1247-1249), Online publication date: 1-May-2021. Volume 205Issue 5May 2021Page: 1303-1309Supplementary Materials Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.Keywordshypothermiarandomized controlled trialkidney neoplasmsgeneral surgeryMetricsAuthor Information Rodney H. Breau Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada *Correspondence: Ottawa Hospital Research Institute, Division of Urology, The University of Ottawa, General Campus, 501 Smyth Rd. Box 222, Ottawa, Ontario K1H 8L6, Canada telephone: 613-737-8899; ext. 73019; E-mail Address: [email protected] More articles by this author Dean A. Fergusson Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada More articles by this author Greg Knoll Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada Division of Nephrology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada More articles by this author Kristen McAlpine Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada More articles by this author Christopher Morash Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada More articles by this author Sonya Cnossen Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada More articles by this author Luke T. Lavallée Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada More articles by this author Ranjeeta Mallick Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada More articles by this author Antonio Finelli Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto, Ontario, Canada More articles by this author Michael A. S. Jewett Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto, Ontario, Canada More articles by this author Bradley C. Leibovich Department of Urology, Mayo Clinic, Rochester, Minnesota More articles by this author Jonathan A. Cook Oxford Clinical Trial Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK More articles by this author Anil Kapoor Division of Urology, McMaster University, Hamilton, Ontario, Canada More articles by this author Frederic Pouliot Division of Urology, Université Laval, Quebec City, Québec, Canada More articles by this author Jonathan Izawa Division of Urology, Department of Surgery, Western University, London, Ontario, Canada More articles by this author Ricardo Rendon Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada More articles by this author Ilias Cagiannos Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada More articles by this author Expand All Supported by the Canadian Institute of Health Research. Advertisement Loading ...