Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
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|ClinicalTrials.gov Identifier: NCT00912184|
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : January 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure, Acute Shock||Device: Standard polyamide high flux membrane Device: High cut-off (super high flux) polyamide membrane||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure|
|Study Start Date :||May 2009|
|Primary Completion Date :||December 2011|
|Study Completion Date :||January 2012|
CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
Device: 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
Active Comparator: 2
CVVH using standard high flux membrane with standard CVVH settings
Device: 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
Other Name: High flux membrane
- The primary outcome measure for this study is noradrenaline free time in the first week after randomization [ Time Frame: 24 months ]
- The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10 [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912184
|Heidelberg, Victoria, Australia, 3084|
|Principal Investigator:||Rafidah Atan, MBBS, FANZCA||Austin Health|