ClinicalTrials.gg
CompletedNCT02341885PEACEUpdated Jan 22, 2016

PrEvalence of Acute and Chronic Kidney Disease Treated by Renal Replacement Therapy

An observational study in Renal Replacement Therapy, Acute Kidney Injury and Chronic End Stage Kidney Disease, sponsored by European Society of Intensive Care Medicine. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-22.

Sponsored by European Society of Intensive Care Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study summary

A prospective international, multi-centre, prevalence study on the epidemiology of the use of renal replacement therapy for ICU patients who have acute kidney injury and chronic end stage kidney disease.

Read the detailed description

Acute kidney injury (AKI) is a common finding in intensive care unit (ICU) patients. Approximately 30 to 65% of patients experience an episode of AKI, and 5% of ICU patients are treated with renal replacement therapy. AKI is associated withimportant short term and long-term morbidity as well as mortality, and therefore also with costs. Finally, there is a close link between chronic kidney disease (CKD) and AKI. CKD patients are at greater risk for developing AKI, and survivors of AKI treated with renal replacement therapy (AKI-RRT), may develop chronic kidney disease (CKD) and end stage kidney disease (ESKD).

Different aspects of RRT modality may impact on outcomes, and data that have emerged over the last decade have improved evidence and also rejected commonly accepted dogma. Initial data suggested a better outcome when a higher dose of treatment was applied [5,6]. However, one small and two large prospective randomised controlled trials failed to reproduce these earlier findings. Observational data seems to suggest that continuous RRT (CRRT) modalities are associated with better outcomes. However, relative small, randomized studies and meta-analyses do not demonstrate such a benefit. Observational data suggests that CRRT is associated with improved renal recovery, and also examining the data from the 2 large randomized studies on intensity of RRT suggest that CRRT confers a benefit. Also, despite RRT being available for over 50 years there are no clear consensus guidelines for the initiation of RRT. A recent survey found that up to 89 different combinations of indications are used. Recently, the Acute Kidney Injury Network and the Kidney Disease: Improving Global Outcomes (KDIGO) group, formulated recommendations for this. Recent observational studies indicated that commonly accepted cut offs such as serum urea concentration are probably not that important. Furthermore, timing of initiation may have an effect on outcome. Some studies suggest that early initiation is associated with better outcome, on the other hand others could not demonstrate a benefit and have even demonstrated inferior outcomes.

The most recent survey in Europe showed that CRRT is the preferred modality among intensivists, and that despite the recently published evidence treatment doses are similar to those of a decade ago.

Data on the use of renal replacement therapy (RRT) for AKI and for CKD in ICU patients are either on specific patient groups, such as cardiac surgery patients, based on surveys, or dates back for at least a decade. Furthermore, these studies suffered from exclusion bias, as patients who fulfilled criteria for initiation of RTT, but who were denied RRT, were not considered. That this may be an important consideration is illustrated by findings from a recent small single centre study that demonstrated similar mortality rate between RIFLE-F patients who were and who were not treated with RRT. Therefore, the Acute Kidney Injury Network (AKIN) recommended measuring the epidemiology of AKI.

The investigators anticipate that the evidence that has been generated on different topics of RRT for ICU patients may have influenced current practice. Also, the investigators anticipate regional differences in RRT practice.

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Conditions studied

  • Renal Replacement Therapy
  • Acute Kidney Injury
  • Chronic End Stage Kidney Disease

Keywords

  • Kidney
  • Renal replacement
  • Acute kidney injury
  • chronic kidney disease
  • Epidemiology
  • Prevalence
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In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's enrollment of 2,000 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

European Society of Intensive Care Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Intensive Care Unit patients diagnosed with acute kidney injury and chronic end stage kidney disease.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients present in the ICU at time of the study data (date starting at 0:00 h, and ending at 23:59 h) (index ICU stay)
  • ≥18 years of age
  • When required by local EC regulations and EC approval, informed consent (written or oral) by the patient or relative.

Exclusion criteria

Exclusion Criteria:

- none

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (actual)
Patient registry
No

Groups and cohorts

  • One Group

    This is an observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.

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What researchers measure

Primary outcomes

  1. Prevalence of severe AKI

    Assessment of the prevalence of severe AKI (defined as KDIGO class 3) and CKD (defined by treatment with renal replacement therapy (RRT)), in ICU patients, present at time of the study inclusion day

    Time frame: with a maximum follow up till day 28 following the index study day

Secondary outcomes

  1. Modalities of RRT

    Assessment of modalities of RRT used for treatment of AKI

    Time frame: with a maximum follow up till day 28 following the index study day

  2. Indications for initiation of RRT

    Assessment of indications for initiation of RRT currently described in literature

    Time frame: with a maximum follow up till day 28 following the index study day

  3. Severity of illness

    Assessment of severity of illness at time of data recording

    Time frame: with a maximum follow up till day 28 following the index study day

  4. Renal outcome

    Assessment of renal outcome

    Time frame: with a maximum follow up till day 28 following the index study day

07

Study locations

1 site
  • All Centres From All Over the World Willing to Contribute Are Welcome
    Brussels, Belgium
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References and documents

Publications

  • 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. PubMed 12352040 ↗
  • 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; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813. PubMed 16106006 ↗
  • Hoste EA, Schurgers M. Epidemiology of acute kidney injury: how big is the problem? Crit Care Med. 2008 Apr;36(4 Suppl):S146-51. doi: 10.1097/CCM.0b013e318168c590. PubMed 18382186 ↗
  • Hoste EAJ, J.A. K, group TAKI-EPIs: The epidemiology of acute kidney injury - Preliminary results of the multicenter international AKI-EPI study. Intensive Care Med 2011, 37: S207
  • Ronco C, Bellomo R, Homel P, Brendolan A, Dan M, Piccinni P, La Greca G. Effects of different doses in continuous veno-venous haemofiltration on outcomes of acute renal failure: a prospective randomised trial. Lancet. 2000 Jul 1;356(9223):26-30. doi: 10.1016/S0140-6736(00)02430-2. PubMed 10892761 ↗
  • Schiffl H, Lang SM, Fischer R. Daily hemodialysis and the outcome of acute renal failure. N Engl J Med. 2002 Jan 31;346(5):305-10. doi: 10.1056/NEJMoa010877. PubMed 11821506 ↗
  • 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 Oct;30(10):2205-11. doi: 10.1097/00003246-200210000-00005. PubMed 12394945 ↗
  • VA/NIH Acute Renal Failure Trial Network; 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 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20. PubMed 18492867 ↗
  • RENAL Replacement Therapy Study Investigators; 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 Oct 22;361(17):1627-38. doi: 10.1056/NEJMoa0902413. PubMed 19846848 ↗
  • Forni LG, Hilton PJ. Continuous hemofiltration in the treatment of acute renal failure. N Engl J Med. 1997 May 1;336(18):1303-9. doi: 10.1056/NEJM199705013361807. No abstract available. PubMed 9113935 ↗
  • Mehta RL, McDonald B, Gabbai FB, Pahl M, Pascual MT, Farkas A, Kaplan RM; Collaborative Group for Treatment of ARF in the ICU. A randomized clinical trial of continuous versus intermittent dialysis for acute renal failure. Kidney Int. 2001 Sep;60(3):1154-63. doi: 10.1046/j.1523-1755.2001.0600031154.x. PubMed 11532112 ↗
  • Vinsonneau C, Camus C, Combes A, Costa de Beauregard MA, Klouche K, Boulain T, Pallot JL, Chiche JD, Taupin P, Landais P, Dhainaut JF; Hemodiafe Study Group. Continuous venovenous haemodiafiltration versus intermittent haemodialysis for acute renal failure in patients with multiple-organ dysfunction syndrome: a multicentre randomised trial. Lancet. 2006 Jul 29;368(9533):379-85. doi: 10.1016/S0140-6736(06)69111-3. PubMed 16876666 ↗
  • Lins RL, Elseviers MM, Van der Niepen P, Hoste E, Malbrain ML, Damas P, Devriendt J; SHARF investigators. Intermittent versus continuous renal replacement therapy for acute kidney injury patients admitted to the intensive care unit: results of a randomized clinical trial. Nephrol Dial Transplant. 2009 Feb;24(2):512-8. doi: 10.1093/ndt/gfn560. Epub 2008 Oct 14. PubMed 18854418 ↗
  • Uehlinger DE, Jakob SM, Ferrari P, Eichelberger M, Huynh-Do U, Marti HP, Mohaupt MG, Vogt B, Rothen HU, Regli B, Takala J, Frey FJ. Comparison of continuous and intermittent renal replacement therapy for acute renal failure. Nephrol Dial Transplant. 2005 Aug;20(8):1630-7. doi: 10.1093/ndt/gfh880. Epub 2005 May 10. PubMed 15886217 ↗
  • Bagshaw SM, Berthiaume LR, Delaney A, Bellomo R. Continuous versus intermittent renal replacement therapy for critically ill patients with acute kidney injury: a meta-analysis. Crit Care Med. 2008 Feb;36(2):610-7. doi: 10.1097/01.CCM.0B013E3181611F552. PubMed 18216610 ↗
  • 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. PubMed 18285591 ↗
  • Bell M, Granath F, Schon S, Lofberg E; SWING; Ekbom A, Martling CR. End-stage renal disease patients on renal replacement therapy in the intensive care unit: short- and long-term outcome. Crit Care Med. 2008 Oct;36(10):2773-8. doi: 10.1097/CCM.0b013e318187815a. PubMed 18766088 ↗
  • Bell M; SWING; Granath F, Schon S, Ekbom A, Martling CR. Continuous renal replacement therapy is associated with less chronic renal failure than intermittent haemodialysis after acute renal failure. Intensive Care Med. 2007 May;33(5):773-780. doi: 10.1007/s00134-007-0590-6. Epub 2007 Mar 16. PubMed 17364165 ↗
  • Uchino S, Bellomo R, Kellum JA, Morimatsu H, Morgera S, Schetz MR, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-Van Straaten HM, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (B.E.S.T. Kidney) Investigators Writing Committee. Patient and kidney survival by dialysis modality in critically ill patients with acute kidney injury. Int J Artif Organs. 2007 Apr;30(4):281-92. doi: 10.1177/039139880703000402. PubMed 17520564 ↗
  • 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 Mar;21(3):690-6. doi: 10.1093/ndt/gfi296. Epub 2005 Dec 2. PubMed 16326743 ↗
  • 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. PubMed 18322044 ↗
  • Ostermann M, Chang RW. Correlation between parameters at initiation of renal replacement therapy and outcome in patients with acute kidney injury. Crit Care. 2009;13(6):R175. doi: 10.1186/cc8154. Epub 2009 Nov 4. PubMed 19889205 ↗
  • De Corte W, Vanholder R, Dhondt AW, De Waele JJ, Decruyenaere J, Danneels C, Claus S, Hoste EA. Serum urea concentration is probably not related to outcome in ICU patients with AKI and renal replacement therapy. Nephrol Dial Transplant. 2011 Oct;26(10):3211-8. doi: 10.1093/ndt/gfq840. Epub 2011 Mar 18. PubMed 21421593 ↗
  • Bouman CS, Forni LG. Initiation of renal replacement therapy: is timing everything? Crit Care. 2010;14(1):107. doi: 10.1186/cc8188. Epub 2010 Feb 10. PubMed 20236445 ↗
  • 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. PubMed 19272549 ↗
  • 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 Aug;52(2):272-84. doi: 10.1053/j.ajkd.2008.02.371. Epub 2008 Jun 18. PubMed 18562058 ↗
  • Kumpers P, Hafer C, Lukasz A, Lichtinghagen R, Brand K, Fliser D, Faulhaber-Walter R, Kielstein JT. Serum neutrophil gelatinase-associated lipocalin at inception of renal replacement therapy predicts survival in critically ill patients with acute kidney injury. Crit Care. 2010;14(1):R9. doi: 10.1186/cc8861. Epub 2010 Feb 1. PubMed 20122150 ↗
  • Vinsonneau C, Monchi M. Too early initiation of renal replacement therapy may be harmful. Crit Care. 2011;15(1):112. doi: 10.1186/cc9405. Epub 2011 Jan 26. PubMed 21345253 ↗
  • Legrand M, Darmon M, Joannidis M, Payen D. Management of renal replacement therapy in ICU patients: an international survey. Intensive Care Med. 2013 Jan;39(1):101-8. doi: 10.1007/s00134-012-2706-x. Epub 2012 Sep 22. PubMed 23001448 ↗
  • Bell M, Liljestam E, Granath F, Fryckstedt J, Ekbom A, Martling CR. Optimal follow-up time after continuous renal replacement therapy in actual renal failure patients stratified with the RIFLE criteria. Nephrol Dial Transplant. 2005 Feb;20(2):354-60. doi: 10.1093/ndt/gfh581. Epub 2004 Dec 14. PubMed 15598666 ↗
  • Ronco C, Ricci Z, Bellomo R. Current worldwide practice of dialysis dose prescription in acute renal failure. Curr Opin Crit Care. 2006 Dec;12(6):551-6. doi: 10.1097/01.ccx.0000247447.17124.05. PubMed 17077685 ↗
  • Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten H, Ronco C, Kellum JA. Continuous renal replacement therapy: a worldwide practice survey. The beginning and ending supportive therapy for the kidney (B.E.S.T. kidney) investigators. Intensive Care Med. 2007 Sep;33(9):1563-70. doi: 10.1007/s00134-007-0754-4. Epub 2007 Jun 27. PubMed 17594074 ↗
  • Mehta RL, Pascual MT, Soroko S, Savage BR, Himmelfarb J, Ikizler TA, Paganini EP, Chertow GM; Program to Improve Care in Acute Renal Disease. Spectrum of acute renal failure in the intensive care unit: the PICARD experience. Kidney Int. 2004 Oct;66(4):1613-21. doi: 10.1111/j.1523-1755.2004.00927.x. PubMed 15458458 ↗
  • Kellum JA, Mehta RL, Levin A, Molitoris BA, Warnock DG, Shah SV, Joannidis M, Ronco C; Acute Kidney Injury Network (AKIN). Development of a clinical research agenda for acute kidney injury using an international, interdisciplinary, three-step modified Delphi process. Clin J Am Soc Nephrol. 2008 May;3(3):887-94. doi: 10.2215/CJN.04891107. Epub 2008 Jan 23. PubMed 18216348 ↗
  • Cerda J, Lameire N, Eggers P, Pannu N, Uchino S, Wang H, Bagga A, Levin A. Epidemiology of acute kidney injury. Clin J Am Soc Nephrol. 2008 May;3(3):881-6. doi: 10.2215/CJN.04961107. Epub 2008 Jan 23. PubMed 18216347 ↗
  • Vaara ST, Korhonen AM, Kaukonen KM, Nisula S, Inkinen O, Hoppu S, Laurila JJ, Mildh L, Reinikainen M, Lund V, Parviainen I, Pettila V; FINNAKI Study Group. Fluid overload is associated with an increased risk for 90-day mortality in critically ill patients with renal replacement therapy: data from the prospective FINNAKI study. Crit Care. 2012 Oct 17;16(5):R197. doi: 10.1186/cc11682. PubMed 23075459 ↗
  • Davenport A. Clinical guidelines for the protection of kidney function and prevention of acute kidney injury in the intensive care unit: common sense rather than magic bullets? Intensive Care Med. 2010 Mar;36(3):379-80. doi: 10.1007/s00134-009-1683-1. No abstract available. PubMed 19921151 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02341885
Lead sponsor
European Society of Intensive Care Medicine
Responsible party
Sponsor
First posted
Jan 19, 2015
Start date
Mar 2015
Primary completion
Aug 2015
Completion
Nov 2015
Last update
Jan 22, 2016

Study contacts

Eric HOSTE, MD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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