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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

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

Shock

Condition category

Condition code

Renal and Urogenital

Kidney disease

Injuries and Accidents

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]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

The primary outcome measure for this study is noradrenaline free time in the first week after randomization

Timepoint [1]

24 months

Secondary outcome [1]

The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10

Timepoint [1]

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?

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

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

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Primary sponsor type

Government body

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/study/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.
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.

Public notes

Contacts

Principal investigator

Name

Rafidah Atan, MBBS, FANZCA

Address

Austin Health

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00912184

Trial Review

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