Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
NCT ID: NCT00912184
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
76 participants
INTERVENTIONAL
2009-05-31
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Super High-Flux - High Volume Dialysis in Sepsis-Induced Acute Renal Failure
NCT00333593
Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane
NCT00824837
Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients
NCT01228123
Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
NCT00004285
Comparing Super High-flux and High-flux Dialyzer Performance Among Hemodialysis Patient With Sepsis : a Randomized Control Trial
NCT06989892
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
It is possible that in using a different and more porous membrane, the removal of cytokines would be much more efficient and that clinical benefits of blood purification would, therefore, be greater.
A membrane of this kind is now available. It is a modification (moderate increase in pore size) of another standard material called polyamide, which has already been used in millions of people for dialysis and haemofiltration. The increased pore size of these new membranes is directed at a more effective removal of middle molecular-weight toxins such as cytokines.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
High cut-off (super high flux) polyamide membrane
CVVH with standard haemofiltration settings; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hour, anticoagulation as clinically indicated, bicarbonate-buffered replacement fluid
2
CVVH using standard high flux membrane with standard CVVH settings
Standard polyamide high flux membrane
Standard haemofiltration; CVVH; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hr, anticoagulation as clinically indicated, bicarbonate buffered replacement fluid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard polyamide high flux membrane
Standard haemofiltration; CVVH; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hr, anticoagulation as clinically indicated, bicarbonate buffered replacement fluid
High cut-off (super high flux) polyamide membrane
CVVH with standard haemofiltration settings; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hour, anticoagulation as clinically indicated, bicarbonate-buffered replacement fluid
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient is on noradrenaline infusion for haemodynamic support
* The patient was commenced on noradrenaline or haemofiltration within the last 12 hours
* The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with different membranes
* The treating clinicians anticipate treating the patient with haemofiltration for at least 72 hours
* Informed consent has been obtained
* The patient fulfils ONE of the following clinical criteria for initiating haemofiltration:
* Oliguria (urine output \< 100 ml/6 hr) 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 mmol/L
* Clinically significant organ oedema in the setting of ARF (e.g., lung)
Exclusion Criteria
* 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 haemofiltration or other dialysis previously during the same hospital admission
* The patient was on maintenance dialysis prior to the current hospitalisation
* Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study
* The patient is pregnant or is breastfeeding
* The patient has previously been enrolled in this study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Austin Health
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rafidah Atan
PhD student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rafidah Atan, MBBS, FANZCA
Role: PRINCIPAL_INVESTIGATOR
Austin Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Austin Hospital
Heidelberg, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ronco C, Tetta C, Mariano F, Wratten ML, Bonello M, Bordoni V, Cardona X, Inguaggiato P, Pilotto L, d'Intini V, Bellomo R. Interpreting the mechanisms of continuous renal replacement therapy in sepsis: the peak concentration hypothesis. Artif Organs. 2003 Sep;27(9):792-801. doi: 10.1046/j.1525-1594.2003.07289.x.
Marshall JC. Inflammation, coagulopathy, and the pathogenesis of multiple organ dysfunction syndrome. Crit Care Med. 2001 Jul;29(7 Suppl):S99-106. doi: 10.1097/00003246-200107001-00032.
Parrillo JE. Pathogenetic mechanisms of septic shock. N Engl J Med. 1993 May 20;328(20):1471-7. doi: 10.1056/NEJM199305203282008. No abstract available.
Bone RC. Sir Isaac Newton, sepsis, SIRS, and CARS. Crit Care Med. 1996 Jul;24(7):1125-8. doi: 10.1097/00003246-199607000-00010. No abstract available.
Pinsky MR, Vincent JL, Deviere J, Alegre M, Kahn RJ, Dupont E. Serum cytokine levels in human septic shock. Relation to multiple-system organ failure and mortality. Chest. 1993 Feb;103(2):565-75. doi: 10.1378/chest.103.2.565.
Hack CE, Aarden LA, Thijs LG. Role of cytokines in sepsis. Adv Immunol. 1997;66:101-95. doi: 10.1016/s0065-2776(08)60597-0. No abstract available.
Dinarello CA. Proinflammatory cytokines. Chest. 2000 Aug;118(2):503-8. doi: 10.1378/chest.118.2.503.
Glauser MP. The inflammatory cytokines. New developments in the pathophysiology and treatment of septic shock. Drugs. 1996;52 Suppl 2:9-17. doi: 10.2165/00003495-199600522-00004.
Bellomo R, Tipping P, Boyce N. Continuous veno-venous hemofiltration with dialysis removes cytokines from the circulation of septic patients. Crit Care Med. 1993 Apr;21(4):522-6. doi: 10.1097/00003246-199304000-00011.
Bellomo R. Continuous hemofiltration as blood purification in sepsis. New Horiz. 1995 Nov;3(4):732-7.
De Vriese AS, Colardyn FA, Philippe JJ, Vanholder RC, De Sutter JH, Lameire NH. Cytokine removal during continuous hemofiltration in septic patients. J Am Soc Nephrol. 1999 Apr;10(4):846-53. doi: 10.1681/ASN.V104846.
Hoffmann JN, Hartl WH, Deppisch R, Faist E, Jochum M, Inthorn D. Hemofiltration in human sepsis: evidence for elimination of immunomodulatory substances. Kidney Int. 1995 Nov;48(5):1563-70. doi: 10.1038/ki.1995.448.
Gasche Y, Pascual M, Suter PM, Favre H, Chevrolet JC, Schifferli JA. Complement depletion during haemofiltration with polyacrilonitrile membranes. Nephrol Dial Transplant. 1996 Jan;11(1):117-9.
Kellum JA, Johnson JP, Kramer D, Palevsky P, Brady JJ, Pinsky MR. Diffusive vs. convective therapy: effects on mediators of inflammation in patient with severe systemic inflammatory response syndrome. Crit Care Med. 1998 Dec;26(12):1995-2000. doi: 10.1097/00003246-199812000-00027.
Cole L, Bellomo R, Hart G, Journois D, Davenport P, Tipping P, Ronco C. A phase II randomized, controlled trial of continuous hemofiltration in sepsis. Crit Care Med. 2002 Jan;30(1):100-6. doi: 10.1097/00003246-200201000-00016.
Lee WC, Uchino S, Fealy N, Baldwin I, Panagiotopoulos S, Goehl H, Morgera S, Neumayer HH, Bellomo R. Super high flux hemodialysis at high dialysate flows: an ex vivo assessment. Int J Artif Organs. 2004 Jan;27(1):24-8. doi: 10.1177/039139880402700106.
Uchino S, Bellomo R, Morimatsu H, Goldsmith D, Davenport P, Cole L, Baldwin I, Panagiotopoulos S, Tipping P, Morgera S, Neumayer HH, Goehl H. Cytokine dialysis: an ex vivo study. ASAIO J. 2002 Nov-Dec;48(6):650-3. doi: 10.1097/00002480-200211000-00013.
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.
Atan R, Peck L, Prowle J, Licari E, Eastwood GM, Storr M, Goehl H, Bellomo R. A Double-Blind Randomized Controlled Trial of High Cutoff Versus Standard Hemofiltration in Critically Ill Patients With Acute Kidney Injury. Crit Care Med. 2018 Oct;46(10):e988-e994. doi: 10.1097/CCM.0000000000003350.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
High cut-off trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.