Augmented Vs. Normal Renal Replacement Therapy in Severe Acute Renal Failure (ARF).

NCT00221013 | Completed Phase 4 DMC

• 2 other identifiers: GI-RE-ARF001-40-R352550
• Study Type: interventional
• Target: 1,508
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine if increasing the dose of continuous renal replacement therapy (CRRT) reduces 90-day all cause mortality in Intensive Care Unit (ICU) patients with severe acute renal failure (ARF).

Conditions

Acute Renal Failure

Keywords

Acute Renal Failure; Continuous Renal Replacement Therapy; Continuous Veno-Venous Haemofiltration; Continuous Veno-Venous Haemodiafiltration; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Death from all causes at 90 days after randomisation.

  Within 90 days after randomisation

Secondary Outcomes (8)

• Death within the in the intensive care unit.

  0 to 90 days

• Death within 28 days of randomisation.

  Within 28 days of randomisation.

• Death prior to hospital discharge.

  0 to 90 days

• Length of ICU stay.

  0 to 90 days

• Length of hospital stay.

  0 to 90 days

Study Arms (2)

Higher intensity CRRT regimen

EXPERIMENTAL

Procedure: "augmented" CRRT regimen

Lower intensity CRRT regimen

ACTIVE COMPARATOR

Procedure: "augmented" CRRT regimen

Interventions

"augmented" CRRT regimen PROCEDURE

We randomly assigned critically ill patients with acute kidney injury to receive CRRT in the form of post-dilution continuous veno-venous hemodiafiltration (CVVHDF) at 25 ml/kg/hr (lower intensity) or 40 ml/kg/hr (higher intensity) of effluent flow.

Higher intensity CRRT regimen; Lower intensity CRRT regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The treating clinician believes that the patient requires CRRT for acute renal failure.
• The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with higher intensity or lower intensity CRRT.
• The treating clinicians anticipate treating the patient with CRRT for at least 72 hours.
• Informed consent has been obtained
• The patient fulfils ONE of the following clinical criteria for initiating CRRT:
• Oliguria (urine output \< 100ml/6hr) that has been unresponsive to fluid resuscitation measures.
• Hyperkalemia (\[K+\] \> 6.5 mmol/L).
• Severe acidemia (pH \< 7.2).
• Urea \> 25 mmol/liter.
• Creatinine \>300 micromol/L in the setting of ARF.
• Clinically significant organ oedema in the setting of ARF (eg: lung).

You may not qualify if:

• Patient age is \<18 years.
• Death is imminent (\<24 hours).
• There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol.
• The patient has been treated with CRRT or other dialysis previously during the same hospital admission.
• The patient was on maintenance dialysis prior to the current hospitalisation.
• The patient's body weight is \<60 kg or \>100kg.
• Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.

Sponsors & Collaborators

• The George Institute: lead
• ANZICS Clinical Trials Group: collaborator

Study Sites (1)

The Austin Hopsital

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (14)

• RENAL Study Investigators. Renal replacement therapy for acute kidney injury in Australian and New Zealand intensive care units: a practice survey. Crit Care Resusc. 2008 Sep;10(3):225-30.

  PMID: 18798721 BACKGROUND

• RENAL Study Investigators; Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Goldsmith D, Myburgh J, Norton R, Scheinkestel C. Design and challenges of the Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (RENAL) Trial: high-dose versus standard-dose hemofiltration in acute renal failure. Blood Purif. 2008;26(5):407-16. doi: 10.1159/000148400.

  PMID: 18856012 BACKGROUND

• Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

  PMID: 36416787 DERIVED

• Naorungroj T, Neto AS, Wang A, Gallagher M, Bellomo R. Renal outcomes according to renal replacement therapy modality and treatment protocol in the ATN and RENAL trials. Crit Care. 2022 Sep 6;26(1):269. doi: 10.1186/s13054-022-04151-5.

  PMID: 36068554 DERIVED

• Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

  PMID: 34519356 DERIVED

• Serpa Neto A, Naorungroj T, Murugan R, Kellum JA, Gallagher M, Bellomo R. Heterogeneity of Effect of Net Ultrafiltration Rate among Critically Ill Adults Receiving Continuous Renal Replacement Therapy. Blood Purif. 2021;50(3):336-346. doi: 10.1159/000510556. Epub 2020 Oct 7.

  PMID: 33027799 DERIVED

• Murugan R, Kerti SJ, Chang CH, Gallagher M, Clermont G, Palevsky PM, Kellum JA, Bellomo R. Association of Net Ultrafiltration Rate With Mortality Among Critically Ill Adults With Acute Kidney Injury Receiving Continuous Venovenous Hemodiafiltration: A Secondary Analysis of the Randomized Evaluation of Normal vs Augmented Level (RENAL) of Renal Replacement Therapy Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195418. doi: 10.1001/jamanetworkopen.2019.5418.

  PMID: 31173127 DERIVED

• Wang AY, Trongtrakul K, Bellomo R, Li Q, Cass A, Gallagher M; RENAL Study Investigators and the ANZICS Clinical Trials Group. HMG-CoA reductase inhibitors (statins) and acute kidney injury: A secondary analysis of renal study outcomes. Nephrology (Carlton). 2019 Sep;24(9):912-918. doi: 10.1111/nep.13597. Epub 2019 May 27.

  PMID: 31058387 DERIVED

• Roberts DM, Liu X, Roberts JA, Nair P, Cole L, Roberts MS, Lipman J, Bellomo R; RENAL Replacement Therapy Study Investigators. A multicenter study on the effect of continuous hemodiafiltration intensity on antibiotic pharmacokinetics. Crit Care. 2015 Mar 13;19(1):84. doi: 10.1186/s13054-015-0818-8.

  PMID: 25881576 DERIVED

• Wang AY, Bellomo R, Ninomiya T, Lo S, Cass A, Jardine M, Gallagher M; RENAL Study Investigators; ANZICS Clinical Trials Group. Angiotensin-converting enzyme inhibitor usage and acute kidney injury: a secondary analysis of RENAL study outcomes. Nephrology (Carlton). 2014 Oct;19(10):617-22. doi: 10.1111/nep.12284.

  PMID: 24894685 DERIVED

• Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Lee J, Lo S, McArthur C, McGuinness S, Myburgh J, Norton R, Scheinkestel C; RENAL Study Investigators; Su S. Calorie intake and patient outcomes in severe acute kidney injury: findings from The Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study trial. Crit Care. 2014 Mar 14;18(2):R45. doi: 10.1186/cc13767.

  PMID: 24629036 DERIVED

• Gallagher M, Cass A, Bellomo R, Finfer S, Gattas D, Lee J, Lo S, McGuinness S, Myburgh J, Parke R, Rajbhandari D; POST-RENAL Study Investigators and the ANZICS Clinical Trials Group. Long-term survival and dialysis dependency following acute kidney injury in intensive care: extended follow-up of a randomized controlled trial. PLoS Med. 2014 Feb 11;11(2):e1001601. doi: 10.1371/journal.pmed.1001601. eCollection 2014 Feb.

  PMID: 24523666 DERIVED

• Bellomo R, Lipcsey M, Calzavacca P, Haase M, Haase-Fielitz A, Licari E, Tee A, Cole L, Cass A, Finfer S, Gallagher M, Lee J, Lo S, McArthur C, McGuinness S, Myburgh J, Scheinkestel C; RENAL Study Investigators and ANZICS Clinical Trials Group. Early acid-base and blood pressure effects of continuous renal replacement therapy intensity in patients with metabolic acidosis. Intensive Care Med. 2013 Mar;39(3):429-36. doi: 10.1007/s00134-012-2800-0. Epub 2013 Jan 11.

  PMID: 23306586 DERIVED

• 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: 19846848 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Prof Rinaldo Bellomo, MD

  Austin Hospital, Melbourne Australia

  STUDY CHAIR

• Alan Cass, MD

  The George Institute

  PRINCIPAL INVESTIGATOR

• Simon Finfer, MD

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

• Carlos Scheinkestel, MD

  The Alfred

  PRINCIPAL INVESTIGATOR

• Robyn Norton, MD

  The George Institute

  PRINCIPAL INVESTIGATOR

• John Myburgh, MD

  St George Hospital (Sydney)

  PRINCIPAL INVESTIGATOR

• Louise Cole, MD

  Nepean Blue Mountains Local Health District

  PRINCIPAL INVESTIGATOR

• Martin Gallagher, MD

  The George Institute

  PRINCIPAL INVESTIGATOR

• Shay McGuinness, MD

  Auckland City Hospital CVICU

  PRINCIPAL INVESTIGATOR

• Colin McArthur, MD

  Auckland City Hospital DCCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 27, 2009

Record last verified: 2009-02

Locations

AU (1)