Early Versus Late Renal Replacement Therapy After Cardiac Surgery
NCT ID: NCT01961999
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1800 participants
INTERVENTIONAL
2011-07-31
2013-10-31
Brief Summary
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Detailed Description
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Outcome parameters were hospital mortality, and ICU and hospital length of stay.
"Early" therapy was started after 6 hours of urine output of less than\<0,5ml/Kg/h, whereas in the "late" group RRT therapy was started on the basis of persistent (lasting more than 12 hours) oliguria.
Data obtained from the database were analyzed using "Statistical Package for Social Science" (SPSS Inc, Chicago, IL). Continuous variables are presented as mean±SD, categorical variables were summarized as frequencies and percentages. The Student t test or Pearson X square test were performed to evaluate differences between groups and to analyze subgroups. For statistics, a p\<0.05 was considered significant.
Power calculation was based on previous reports13 on cumulative mortality following cardiac surgery. 50% reduction of mortality was hypothesized when the more conservative approach to cardiac surgery-AKI was applied. The suggested number of patients was about 900 patients per group.
The main limitation of the present study include the non-classical randomization, nevertheless we conducted an interventional trial comparing two treatment strategies in two different groups of patients, prospectively followed and suitable for both treatments.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early RRT
In the "early" arm renal replacement therapy was started on the basis of refractory oliguria: urine output \<0,5ml/Kg/h for \> 6 hours
Early RRT
In the "early" arm renal replacement therapy was started on the basis of refractory oliguria: urine output \<0,5ml/Kg/h for \> 6 hours
Late RRT
In the "late" arm at least one the following criteria must be fulfilled prior to initiation of renal replacement therapy:
* persistent and refractory oliguria (\<0,5 ml/Kg/h \>12h), despite therapy
* refractory extravascular fluid overload
* azotemia \> 40mmol/L or 240 mg/dL
* metabolic acidosis (pH\<7,2)
* hyperkaliemia (k+\>6 mmol/L)
Late RRT
In the "late" arm at least one the following criteria must be fulfilled prior to initiation of renal replacement therapy:
persistent and refractory oliguria (\<0,5ml/Kg/h \>12h), despite therapy refractory extravascular fluid overload azotemia \>40mmol/L or 240mg/dL metabolic acidosis (pH\<7,2) hyperkaliemia (k+\>6mmol/L)
Interventions
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Early RRT
In the "early" arm renal replacement therapy was started on the basis of refractory oliguria: urine output \<0,5ml/Kg/h for \> 6 hours
Late RRT
In the "late" arm at least one the following criteria must be fulfilled prior to initiation of renal replacement therapy:
persistent and refractory oliguria (\<0,5ml/Kg/h \>12h), despite therapy refractory extravascular fluid overload azotemia \>40mmol/L or 240mg/dL metabolic acidosis (pH\<7,2) hyperkaliemia (k+\>6mmol/L)
Eligibility Criteria
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Inclusion Criteria
* Planned use of extracorporeal circulation
Exclusion Criteria
* Planned off-pump cardiac surgery
* Pts (or proxy) did not sign informed consent
18 Years
ALL
No
Sponsors
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Ospedali Riuniti Ancona
OTHER
Responsible Party
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Giuseppe Crescenzi M.D.
Medical Doctor Cardiac Surgery intensive care Unit
Principal Investigators
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Giuseppe Crescenzi, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedali Riuniti di Ancona
Locations
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Cardiac Surgery department of Ospedali Riuniti
Ancona, AN, Italy
Countries
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References
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Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
Gibney N, Hoste E, Burdmann EA, Bunchman T, Kher V, Viswanathan R, Mehta RL, Ronco C. Timing of initiation and discontinuation of renal replacement therapy in AKI: unanswered key questions. Clin J Am Soc Nephrol. 2008 May;3(3):876-80. doi: 10.2215/CJN.04871107. Epub 2008 Mar 5.
Chertow GM, Lazarus JM, Christiansen CL, Cook EF, Hammermeister KE, Grover F, Daley J. Preoperative renal risk stratification. Circulation. 1997 Feb 18;95(4):878-84. doi: 10.1161/01.cir.95.4.878.
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Prowle JR, Bellomo R. Continuous renal replacement therapy: recent advances and future research. Nat Rev Nephrol. 2010 Sep;6(9):521-9. doi: 10.1038/nrneph.2010.100. Epub 2010 Jul 20.
Bagshaw SM, Gibney RT, McAlister FA, Bellomo R. The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury. Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.
Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008 Apr;135(4):732-8. doi: 10.1016/j.jtcvs.2007.12.002. No abstract available.
Kuitunen A, Vento A, Suojaranta-Ylinen R, Pettila V. Acute renal failure after cardiac surgery: evaluation of the RIFLE classification. Ann Thorac Surg. 2006 Feb;81(2):542-6. doi: 10.1016/j.athoracsur.2005.07.047.
Uchino S, Bellomo R, Goldsmith D, Bates S, Ronco C. An assessment of the RIFLE criteria for acute renal failure in hospitalized patients. Crit Care Med. 2006 Jul;34(7):1913-7. doi: 10.1097/01.CCM.0000224227.70642.4F.
Cooper WA, O'Brien SM, Thourani VH, Guyton RA, Bridges CR, Szczech LA, Petersen R, Peterson ED. Impact of renal dysfunction on outcomes of coronary artery bypass surgery: results from the Society of Thoracic Surgeons National Adult Cardiac Database. Circulation. 2006 Feb 28;113(8):1063-70. doi: 10.1161/CIRCULATIONAHA.105.580084. Epub 2006 Feb 20.
Pierri MD, Capestro F, Zingaro C, Torracca L. The changing face of cardiac surgery patients: an insight into a Mediterranean region. Eur J Cardiothorac Surg. 2010 Oct;38(4):407-13. doi: 10.1016/j.ejcts.2010.02.040.
Bove T, Calabro MG, Landoni G, Aletti G, Marino G, Crescenzi G, Rosica C, Zangrillo A. The incidence and risk of acute renal failure after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):442-5. doi: 10.1053/j.jvca.2004.05.021.
Chertow GM, Levy EM, Hammermeister KE, Grover F, Daley J. Independent association between acute renal failure and mortality following cardiac surgery. Am J Med. 1998 Apr;104(4):343-8. doi: 10.1016/s0002-9343(98)00058-8.
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; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Timing of renal replacement therapy and clinical outcomes in critically ill patients with severe acute kidney injury. J Crit Care. 2009 Mar;24(1):129-40. doi: 10.1016/j.jcrc.2007.12.017. Epub 2008 Apr 18.
Pannu N, Klarenbach S, Wiebe N, Manns B, Tonelli M; Alberta Kidney Disease Network. Renal replacement therapy in patients with acute renal failure: a systematic review. JAMA. 2008 Feb 20;299(7):793-805. doi: 10.1001/jama.299.7.793.
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Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, Le Gall JR, Druml W. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002 Sep;30(9):2051-8. doi: 10.1097/00003246-200209000-00016.
Ympa YP, Sakr Y, Reinhart K, Vincent JL. Has mortality from acute renal failure decreased? A systematic review of the literature. Am J Med. 2005 Aug;118(8):827-32. doi: 10.1016/j.amjmed.2005.01.069.
Kellum JA. Acute kidney injury. Crit Care Med. 2008 Apr;36(4 Suppl):S141-5. doi: 10.1097/CCM.0b013e318168c4a4.
Crescenzi G, Torracca L, Pierri MD, Rosica C, Munch C, Capestro F. 'Early' and 'late' timing for renal replacement therapy in acute kidney injury after cardiac surgery: a prospective, interventional, controlled, single-centre trial. Interact Cardiovasc Thorac Surg. 2015 May;20(5):616-21. doi: 10.1093/icvts/ivv025. Epub 2015 Feb 18.
Other Identifiers
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ANCCH01
Identifier Type: -
Identifier Source: org_study_id