Acute Renal FailurePhase 4NCT00221013
Augmented Vs. Normal Renal Replacement Therapy in Severe Acute Renal Failure (ARF).
A Phase 4 study testing "augmented" CRRT regimen in people with Acute Renal Failure, run by The George Institute at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- "augmented" CRRT regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,508 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2005to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Unblinded, Open Label, Randomised, Controlled Trial to Assess the Effect of Augmented Vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-Day All-Cause Mortality of Intensive Care Unit Patients With Severe Acute Renal Failure (ARF).
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).
Read the detailed description
Study Title - Multicentre, Unblinded, Randomised, Controlled Trial to assess the effect of Augmented vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-day all-cause mortality of Intensive Care Unit Patients with Severe Acute Renal Failure (ARF).
Clinical Phase - IV
Study Rationale - This study will provide high quality evidence from a mulit-center randomised controlled trial about the comparative effects of different targets for CRRT dose in patients with ARF treated in the Australasian intensive care setting. This evidence will have direct relevance to decisions about the care of critically ill patients admitted to intensive care units in Australia and New Zealand. If this study confirms the treatment effect reported in the Lancet study, augmented dose CRRT is likely too become the standard of treatment, saving 250-300 lives/year in Australia and 15,000 lives/year worldwide.
Trial Design - The proposed study will compare an "augmented" CRRT regimen to deliver an effluent rate of 40 ml/kg/hr compared to "normal" CRRT at an effluent rate of 25ml/kg/hr in ICU patients with severe ARF.
Subject Participation - 90 days
Rationale for Number of Subjects - Assuming a 90-day mortality rate of 60% in our control group the study of 1,500 patients will have 90% power of detecting an 8.5% absolute reduction from a 90-day mortality of 60% in the control group to 51.5% in the intervention group (P<0.05).
Approximate duration of Study - 36 months
Study Objective(s)
Primary - The primary study outcome is death from all causes at 90 days after randomisation.
Secondary
- Death within the in the intensive care unit.
- Death within 28 days of randomisation.
- Death prior to hospital discharge.
- Length of ICU stay.
- Length of hospital stay.
- The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
- CRRT-free days.
- Dialysis-independent survival.
Criteria for Inclusion
- 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 at least 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).
Criteria for Exclusion
- 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 >120kg.
- Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
Approximate Number of Subjects - 1500
Approximate Number of Study Centres - 35 centres distributed in both Australia and New Zealand will participate in the study.
Treatment Administration - Each participant will be randomised to receive CRRT in the technical form of CVVHDF either at an intensity of 25ml/kg/hr of effluent flow(normal CRRT) or 40 ml/kg/hr of effluent flow (augmented CRRT).
Safety Evaluation - Safety for individual patients will be assessed on an ongoing basis by physical examination, including vital signs, outputs from dialysis machine records, laboratory assessments, and monitoring of adverse events. Overall study safety will be ensured by an Independent Data Safety Monitoring Committee, independent from all Trial investigators, which will perform ongoing review of predefined safety parameters and study conduct.
Efficacy Evaluation - Overall survival at 90 days post randomisation
Statistical Analysis - The interim analyses will be conducted when approximately 500 and 1000 patients have completed 90 day follow up, as dictated by the Data Safety Monitoring Committee. The final analysis will occur when outcome data for the target 1500 subjects is available. At interim and final analysis, the baseline and outcome variables will be compared using Students t test, Chi squared and the Mann-Whitney U test as appropriate. Survival analysis will be assessed using the Mantel-Cox test. The final statistical analysis will be performed according to a pre-determined statistical analysis plan (Critical Care and Resuscitation, 2009 in press).
- Conditions
- Acute Renal Failure
- Being tested
- "augmented" CRRT regimen
- Keywords
- Acute Renal Failure, Continuous Renal Replacement Therapy, Continuous Veno-Venous Haemofiltration, Continuous Veno-Venous Haemodiafiltration, Renal Replacement Therapy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"augmented" CRRT regimenProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Higher intensity CRRT regimen | Experimental | Not described Receives: Procedure: "augmented" CRRT regimen |
| Lower intensity CRRT regimen | Active comparator | Not described Receives: Procedure: "augmented" CRRT regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from all causes at 90 days after randomisation.
Measured: Within 90 days after randomisation
Secondary outcomes (8)
Death within the in the intensive care unit.
Measured: 0 to 90 days
Death within 28 days of randomisation.
Measured: Within 28 days of randomisation.
Death prior to hospital discharge.
Measured: 0 to 90 days
Length of ICU stay.
Measured: 0 to 90 days
Length of hospital stay.
Measured: 0 to 90 days
The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
Measured: 0 to 90 days
CRRT-free days.
Measured: 0 to 90 days
Dialysis-independent survival.
Measured: 0 to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ANZICS Clinical Trials Group
- Investigators
- Prof Rinaldo Bellomo, MD, Study chair, Austin Hospital, Melbourne AustraliaAlan Cass, MD, Principal investigator, The George InstituteSimon Finfer, MD, Principal investigator, Royal North Shore HospitalCarlos Scheinkestel, MD, Principal investigator, The AlfredRobyn Norton, MD, Principal investigator, The George InstituteJohn Myburgh, MD, Principal investigator, St George Hospital (Sydney)Louise Cole, MD, Principal investigator, Nepean Blue Mountains Local Health DistrictMartin Gallagher, MD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221013
- Sponsor's protocol ID
- GI-RE-ARF001-40-R
- Other IDs
- 352550
- Status last verified
- Feb 2009
- First submitted
- 14 Sep 2005
- Last updated
- 27 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18798721RENAL 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.
PubMed 18856012Fayad 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.
PubMed 36416787Naorungroj 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.
PubMed 36068554Tsujimoto 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.
PubMed 34519356Serpa 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.
PubMed 33027799Murugan 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.
PubMed 31173127Wang 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.
PubMed 31058387Roberts 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.
PubMed 25881576Wang 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.
PubMed 24894685Bellomo 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.
PubMed 24629036Gallagher 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.
PubMed 24523666Bellomo 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.
PubMed 23306586RENAL 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Unblinded, Open Label, Randomised, Controlled Trial to Assess the Effect of Augmented Vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-Day All-Cause Mortality of Intensive Care Unit Patients With Severe Acute Renal Failure (ARF).
- ClinicalTrials.gov ID
- NCT00221013
- Acronym / sponsor ID
- GI-RE-ARF001-40-R
- Conditions
- Acute Renal Failure
- Keywords
- Acute Renal Failure, Continuous Renal Replacement Therapy, Continuous Veno-Venous Haemofiltration, Continuous Veno-Venous Haemodiafiltration, Renal Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,508 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- ANZICS Clinical Trials Group
- Study start
- Nov 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study Title - Multicentre, Unblinded, Randomised, Controlled Trial to assess the effect of Augmented vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-day all-cause mortality of Intensive Care Unit Patients with Severe Acute Renal Failure (ARF).
Clinical Phase - IV
Study Rationale - This study will provide high quality evidence from a mulit-center randomised controlled trial about the comparative effects of different targets for CRRT dose in patients with ARF treated in the Australasian intensive care setting. This evidence will have direct relevance to decisions about the care of critically ill patients admitted to intensive care units in Australia and New Zealand. If this study confirms the treatment effect reported in the Lancet study, augmented dose CRRT is likely too become the standard of treatment, saving 250-300 lives/year in Australia and 15,000 lives/year worldwide.
Trial Design - The proposed study will compare an "augmented" CRRT regimen to deliver an effluent rate of 40 ml/kg/hr compared to "normal" CRRT at an effluent rate of 25ml/kg/hr in ICU patients with severe ARF.
Subject Participation - 90 days
Rationale for Number of Subjects - Assuming a 90-day mortality rate of 60% in our control group the study of 1,500 patients will have 90% power of detecting an 8.5% absolute reduction from a 90-day mortality of 60% in the control group to 51.5% in the intervention group (P<0.05).
Approximate duration of Study - 36 months
Study Objective(s)
Primary - The primary study outcome is death from all causes at 90 days after randomisation.
Secondary
- Death within the in the intensive care unit.
- Death within 28 days of randomisation.
- Death prior to hospital discharge.
- Length of ICU stay.
- Length of hospital stay.
- The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
- CRRT-free days.
- Dialysis-independent survival.
Criteria for Inclusion
- 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 at least 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).
Criteria for Exclusion
- 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 >120kg.
- Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
Approximate Number of Subjects - 1500
Approximate Number of Study Centres - 35 centres distributed in both Australia and New Zealand will participate in the study.
Treatment Administration - Each participant will be randomised to receive CRRT in the technical form of CVVHDF either at an intensity of 25ml/kg/hr of effluent flow(normal CRRT) or 40 ml/kg/hr of effluent flow (augmented CRRT).
Safety Evaluation - Safety for individual patients will be assessed on an ongoing basis by physical examination, including vital signs, outputs from dialysis machine records, laboratory assessments, and monitoring of adverse events. Overall study safety will be ensured by an Independent Data Safety Monitoring Committee, independent from all Trial investigators, which will perform ongoing review of predefined safety parameters and study conduct.
Efficacy Evaluation - Overall survival at 90 days post randomisation
Statistical Analysis - The interim analyses will be conducted when approximately 500 and 1000 patients have completed 90 day follow up, as dictated by the Data Safety Monitoring Committee. The final analysis will occur when outcome data for the target 1500 subjects is available. At interim and final analysis, the baseline and outcome variables will be compared using Students t test, Chi squared and the Mann-Whitney U test as appropriate. Survival analysis will be assessed using the Mantel-Cox test. The final statistical analysis will be performed according to a pre-determined statistical analysis plan (Critical Care and Resuscitation, 2009 in press).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher intensity CRRT regimen | Experimental | Procedure: "augmented" CRRT regimen |
| Lower intensity CRRT regimen | Active comparator | Procedure: "augmented" CRRT regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "augmented" CRRT regimenWe 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. | Procedure or surgery | Higher intensity CRRT regimen, Lower intensity CRRT regimen |
Primary outcome
Death from all causes at 90 days after randomisation.
Time frame: Within 90 days after randomisation
8 secondary outcomes
Death within the in the intensive care unit.
Time frame: 0 to 90 days
Death within 28 days of randomisation.
Time frame: Within 28 days of randomisation.
Death prior to hospital discharge.
Time frame: 0 to 90 days
Length of ICU stay.
Time frame: 0 to 90 days
Length of hospital stay.
Time frame: 0 to 90 days
The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).
Time frame: 0 to 90 days
CRRT-free days.
Time frame: 0 to 90 days
Dialysis-independent survival.
Time frame: 0 to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2009.
- Background: PubMed 18798721RENAL 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.
- Background: PubMed 18856012RENAL 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.
- Derived from this study: PubMed 36416787Fayad 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.
- Derived from this study: PubMed 36068554Naorungroj 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.
- Derived from this study: PubMed 34519356Tsujimoto 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.
- Derived from this study: PubMed 33027799Serpa 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.
- Derived from this study: PubMed 31173127Murugan 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.
- Derived from this study: PubMed 31058387Wang 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.
- Derived from this study: PubMed 25881576Roberts 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.
- Derived from this study: PubMed 24894685Wang 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.
- Derived from this study: PubMed 24629036Bellomo 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.
- Derived from this study: PubMed 24523666Gallagher 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.
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End-Stage Renal Disease, Renal Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Rinaldo Bellomo, MD study chair
Austin Hospital, Melbourne Australia
Alan Cass, MD principal investigator
The George Institute
Simon Finfer, MD principal investigator
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "augmented" CRRT regimen in people with Acute Renal Failure, run by The George Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from all causes at 90 days after randomisation. (time frame: Within 90 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221013, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2009.