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Kidney Failure, AcutePhase 1/2NCT00912184

Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure

A Phase 1/2 study testing Standard polyamide high flux membrane and High cut-off (super high flux) polyamide membrane in people with Kidney Failure, Acute and Shock, run by Austin Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Failure, Acute, Shock
What is being tested?
Standard polyamide high flux membrane and High cut-off (super high flux) polyamide membrane
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteAustralia
Study dates
May 2009to Jan 2012
Phase
Phase 1/2
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 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
Show all 13Show fewer
  • 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)

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 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Austin Hospital

    Heidelberg, Victoria, 3084

Other trials in Australia

About this study

Official title: Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure

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.

Read the detailed description

During acute renal failure, small and middle molecular-weight toxins accumulate. These molecules are difficult to remove by standard haemofiltration. Accordingly, they accumulate and contribute to morbidity in long-term dialysis patients. Molecules such as cytokines have been shown to play a central pathogenic role in critical illness. In critically ill acute renal failure patients, they accumulate in serum and likely contribute to much morbidity (fever, low blood pressure, myocardial dysfunction, renal failure itself etc.) Therefore, the removal of cytokines appears desirable. Although different approaches have been undertaken, all have had limited success due to complexity, limited efficacy or uncertain clinical response [10-15].

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.

Being tested
Standard polyamide high flux membrane, High cut-off (super high flux) polyamide membrane
Keywords
Kidney failure, acute, Shock, Toxins, biological, Hemofiltration, High cut off/super high flux membranes
Medical subject headings
Acute Kidney Injury, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard polyamide high flux membraneDevice

    Also called 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 membraneDevice

    Also called P2SH, Super high flux membrane

    CVVH with standard haemofiltration settings; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hour, anticoagulation as clinically indicated, bicarbonate-buffered replacement fluid

Study groups in NCT00912184
Study groupRoleWhat they receive
1ExperimentalCVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
Receives: Device: High cut-off (super high flux) polyamide membrane
2Active comparatorCVVH using standard high flux membrane with standard CVVH settings
Receives: Device: Standard polyamide high flux membrane

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 months

Secondary outcomes (1)

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2011
  4. Study completionJan 2012

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00912184
Sponsor's protocol ID
High cut-off trial
Status last verified
Jan 2012
First submitted
1 Jun 2009
Last updated
31 Jan 2012
Results posted
No

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.

    PubMed 12940901

  • 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.

    PubMed 11445742

  • 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.

    PubMed 8479467

  • 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.

    PubMed 8674323

  • 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.

    PubMed 8432155

  • 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.

    PubMed 9328641

  • Dinarello CA. Proinflammatory cytokines. Chest. 2000 Aug;118(2):503-8. doi: 10.1378/chest.118.2.503.

    PubMed 10936147

  • 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.

    PubMed 8869831

  • 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.

    PubMed 8472571

  • Bellomo R. Continuous hemofiltration as blood purification in sepsis. New Horiz. 1995 Nov;3(4):732-7.

    PubMed 8574604

  • 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.

    PubMed 10203370

  • 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.

    PubMed 8544415

  • 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.

    PubMed 8649617

  • 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.

    PubMed 9875910

  • 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.

    PubMed 11902250

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Standard polyamide high flux membrane and High cut-off (super high flux) polyamide membrane in people with Kidney Failure, Acute and Shock, run by Austin Health 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 13 inclusion and 8 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 31 Jan 2012. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The primary outcome measure for this study is noradrenaline free time in the first week after randomization (time frame: 24 months). 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 NCT00912184, which also lists 19 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 31 Jan 2012.

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