NCT02341885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 12, 2015

Last Update Submit

January 21, 2016

Conditions

Renal Replacement TherapyAcute Kidney InjuryChronic End Stage Kidney Disease

Keywords

KidneyRenal replacementAcute kidney injurychronic kidney diseaseEpidemiologyPrevalence

Outcome Measures

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

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

Secondary Outcomes (4)

  • Modalities of RRT

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

  • Indications for initiation of RRT

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

  • Severity of illness

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

  • Renal outcome

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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All Centres From All Over the World Willing to Contribute Are Welcome

Brussels, Belgium

Location

Related Publications (37)

  • 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.

    PMID: 12352040BACKGROUND

  • 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.

    PMID: 16106006BACKGROUND

  • 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.

    PMID: 18382186BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 10892761BACKGROUND

  • 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.

    PMID: 11821506BACKGROUND

  • 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.

    PMID: 12394945BACKGROUND

  • 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.

    PMID: 18492867BACKGROUND

  • 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.

    PMID: 19846848BACKGROUND

  • 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.

    PMID: 9113935BACKGROUND

  • 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.

    PMID: 11532112BACKGROUND

  • 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.

    PMID: 16876666BACKGROUND

  • 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.

    PMID: 18854418BACKGROUND

  • 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.

    PMID: 15886217BACKGROUND

  • 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.

    PMID: 18216610BACKGROUND

  • 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.

    PMID: 18285591BACKGROUND

  • 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.

    PMID: 18766088BACKGROUND

  • 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.

    PMID: 17364165BACKGROUND

  • 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.

    PMID: 17520564BACKGROUND

  • 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.

    PMID: 16326743BACKGROUND

  • 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.

    PMID: 18322044BACKGROUND

  • 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.

    PMID: 19889205BACKGROUND

  • 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.

    PMID: 21421593BACKGROUND

  • 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.

    PMID: 20236445BACKGROUND

  • 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.

    PMID: 19272549BACKGROUND

  • 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.

    PMID: 18562058BACKGROUND

  • 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.

    PMID: 20122150BACKGROUND

  • 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.

    PMID: 21345253BACKGROUND

  • 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.

    PMID: 23001448BACKGROUND

  • 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.

    PMID: 15598666BACKGROUND

  • 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.

    PMID: 17077685BACKGROUND

  • 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.

    PMID: 17594074BACKGROUND

  • 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.

    PMID: 15458458BACKGROUND

  • 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.

    PMID: 18216348BACKGROUND

  • 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.

    PMID: 18216347BACKGROUND

  • 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.

    PMID: 23075459BACKGROUND

  • 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.

    PMID: 19921151BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric HOSTE, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

BE(1)