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Trial details imported from ClinicalTrials.gov
Ethics application status
Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure
Secondary ID 
High cut-off trial
Universal Trial Number (UTN)
Kidney Failure, Acute
Renal and Urogenital
Injuries and Accidents
Other injuries and accidents
Description of intervention(s) / exposure
Treatment: Devices - Standard polyamide high flux membrane
Treatment: Devices - High cut-off (super high flux) polyamide membrane
Experimental: 1 - CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
Active Comparator: 2 - CVVH using standard high flux membrane with standard CVVH settings
Treatment: Devices: 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
Treatment: Devices: 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
Intervention code 
Comparator / control treatment
Primary outcome 
The primary outcome measure for this study is noradrenaline free time in the first week after randomization
Secondary outcome 
The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10
Key inclusion criteria
- The treating clinician believes that the patient requires haemofiltration for acute
- 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
- Oliguria (urine output < 100 ml/6 hr) that has been unresponsive to fluid
- 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)
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- 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 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
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Austin Hospital - Heidelberg
Recruitment postcode(s) 
Ethics application status
This trial aims to study the effect of combining continuous and a new polyamide membrane with
larger pores in the treatment of critically ill patients with acute renal failure and low
blood pressure (shock) requiring noradrenaline. The investigators wish to compare the
clinical effect of this new therapy to that of haemofiltration with a standard membrane.
Trial related presentations / publications
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. Review.
Marshall JC. Inflammation, coagulopathy, and the pathogenesis of multiple organ dysfunction syndrome. Crit Care Med. 2001 Jul;29(7 Suppl):S99-106. Review.
Parrillo JE. Pathogenetic mechanisms of septic shock. N Engl J Med. 1993 May 20;328(20):1471-7. Review.
Bone RC. Sir Isaac Newton, sepsis, SIRS, and CARS. Crit Care Med. 1996 Jul;24(7):1125-8.
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.
Hack CE, Aarden LA, Thijs LG. Role of cytokines in sepsis. Adv Immunol. 1997;66:101-95. Review.
Dinarello CA. Proinflammatory cytokines. Chest. 2000 Aug;118(2):503-8. Review.
Glauser MP. The inflammatory cytokines. New developments in the pathophysiology and treatment of septic shock. Drugs. 1996;52 Suppl 2:9-17. Review.
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.
Bellomo R. Continuous hemofiltration as blood purification in sepsis. New Horiz. 1995 Nov;3(4):732-7. Review.
De Vriese AS, Colardyn FA, Philippé 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.
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.
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.
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.
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.
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.
Rafidah Atan, MBBS, FANZCA