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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00912184




Registration number
NCT00912184
Ethics application status
Date submitted
1/06/2009
Date registered
3/06/2009
Date last updated
31/01/2012

Titles & IDs
Public title
Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
Scientific title
Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure
Secondary ID [1] 0 0
High cut-off trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure, Acute 0 0
Shock 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome measure for this study is noradrenaline free time in the first week after randomization
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10
Timepoint [1] 0 0
24 months

Eligibility
Key inclusion criteria
- The treating clinician believes that the patient requires haemofiltration for acute
renal failure

- 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00912184
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. 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.
Public notes

Contacts
Principal investigator
Name 0 0
Rafidah Atan, MBBS, FANZCA
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00912184