NCT01961999

Brief Summary

The question of timing of initiation of renal replacement therapy (RRT), "early" versus "late", has seldom been the focus of high-quality or rigorous evaluation. As a consequence, initiatives aimed at identifying the "optimal timing of initiation of RRT" in acute kidney injury (AKI) have been given the highest priority for investigation by the Acute Kidney Injury Network (AKIN). Accordingly, the investigators conducted a prospective, controlled, interventional trial, comparing two treatment groups in which the only variable was the RRT initiation strategy, to determine whether "early" versus "late" initiation in patients with AKI after cardiac surgery is associated with a survival benefit or more favorable outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

October 6, 2013

Last Update Submit

October 9, 2013

Conditions

Acute Kidney Injury

Keywords

Acute kidney injuryCardiac surgeryRenal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • operative mortality

    death during the same hospitalization as surgery, or after discharge, but within 30 days of surgery

    death during the same hospitalization as surgery, or after discharge, but within 30 days of surgery

Secondary Outcomes (2)

  • Hospital length of stay

    during the same hospitalization for surgery, but within 30 days from surgery

  • ICU length of stay

    during the same hospitalization for surgery, but within 30 days from surgery

Study Arms (2)

Early RRT

ACTIVE COMPARATOR

In the "early" arm renal replacement therapy was started on the basis of refractory oliguria: urine output \<0,5ml/Kg/h for \> 6 hours

Procedure: Early RRT

Late RRT

ACTIVE COMPARATOR

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)

Procedure: Late RRT

Interventions

Early RRTPROCEDURE

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
Late RRTPROCEDURE

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)

Late RRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients submitted to cardiac surgery at "Ospedali Riuniti" of Ancona during the study period
  • Planned use of extracorporeal circulation

You may not qualify if:

  • Preoperative dialysis
  • Planned off-pump cardiac surgery
  • Pts (or proxy) did not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery department of Ospedali Riuniti

Ancona, AN, 60100, Italy

Location

Related Publications (22)

  • Karkouti K, Wijeysundera DN, Yau TM, Callum JL, Cheng DC, Crowther M, Dupuis JY, Fremes SE, Kent B, Laflamme C, Lamy A, Legare JF, Mazer CD, McCluskey SA, Rubens FD, Sawchuk C, Beattie WS. Acute kidney injury after cardiac surgery: focus on modifiable risk factors. Circulation. 2009 Feb 3;119(4):495-502. doi: 10.1161/CIRCULATIONAHA.108.786913. Epub 2009 Jan 19.

    PMID: 19153273BACKGROUND

  • 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.

    PMID: 15312219BACKGROUND

  • 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

  • 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.

    PMID: 9054745BACKGROUND

  • 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

  • Korevaar JC, Jansen MA, Dekker FW, Jager KJ, Boeschoten EW, Krediet RT, Bossuyt PM; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group. When to initiate dialysis: effect of proposed US guidelines on survival. Lancet. 2001 Sep 29;358(9287):1046-50. doi: 10.1016/S0140-6736(01)06180-3.

    PMID: 11589934BACKGROUND

  • 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.

    PMID: 20644583BACKGROUND

  • 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.

    PMID: 20459801BACKGROUND

  • 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.

    PMID: 18374749BACKGROUND

  • 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.

    PMID: 16427848BACKGROUND

  • 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.

    PMID: 16715038BACKGROUND

  • 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.

    PMID: 16490821BACKGROUND

  • 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.

    PMID: 20399675BACKGROUND

  • 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.

    PMID: 15365924BACKGROUND

  • 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.

    PMID: 9576407BACKGROUND

  • 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

  • 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

  • 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 Soc Nephrol. 2006 Sep;1(5):915-9. doi: 10.2215/CJN.01430406. Epub 2006 Jul 6.

    PMID: 17699307BACKGROUND

  • 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

  • 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.

    PMID: 16084171BACKGROUND

  • Kellum JA. Acute kidney injury. Crit Care Med. 2008 Apr;36(4 Suppl):S141-5. doi: 10.1097/CCM.0b013e318168c4a4.

    PMID: 18382185BACKGROUND

  • 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.

    PMID: 25694207DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Giuseppe Crescenzi, MD

    Ospedali Riuniti di Ancona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor Cardiac Surgery intensive care Unit

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 14, 2013

Study Start

July 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations

IT(1)