A Phase 3 interventional study of Standard dose of dialysis and High dose of dialysis in Acute Renal Failure, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-04-14.
Sponsored by University of Alabama at Birmingham · Phase 3, Interventional, and Treatment
In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU has remained unchanged at greater than 50%, despite improvements in dialysis technology.
The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration rate of 20 ml/hr/kg.
Although the worldwide standard for renal replacement therapy is intermittent hemodialysis(IHD), continuous renal replacement therapy (CRRT) has emerged as an alternative form of renal replacement therapy in the critical care setting due to its advantages of slow continuous fluid removal, steady acid-base correction, and hemodynamic stability.
There are no standard protocols for initiating or administering CRRT, and practice patterns vary widely among institutions, with less than 25% of patients with ARF in the ICU receiving this therapy in the United States.
Various CRRT modalities are available that use diffusion, convection, or a combination of both to obtain adequate solute clearance. However, there is no consensus as to the optimal dialysis modality, adequate dialysis dose, or optimal clearance modality (convection vs. diffusion). Clinical trials are needed to determine the optimal method of administering CRRT, with respect to modality, dose of dialysis, and time of initiation of therapy.
Although some studies suggest that a higher dose of dialysis improves survival, there have been no prospective randomized studies comparing the effectiveness of diffusion and convection, combined together, for solute clearance.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 200 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
ARF defined by at least one of the following:
Exclusion Criteria
Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
Device: Standard dose of dialysis
High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
Device: High dose of dialysis
Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr
Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)
The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.
Time frame: Up to 30 days
Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT
The number of participants who recover renal function at 30 days after enrollment in each arm.
Time frame: Up to 30 days
| Milestone | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) |
|---|---|---|
| Started | 100 | 100 |
| Completed | 100 | 100 |
| Not completed | 0 | 0 |
The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.
| participants | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) |
|---|---|---|
| Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | 56 | 49 |
The number of participants who recover renal function at 30 days after enrollment in each arm.
| Participants | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) |
|---|---|---|
| Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT | 37 | 28 |
Collected over Time on continuous venovenous hemodiafiltration up to 30 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | — | 63/100 (63%) | 0/100 (0%) |
| High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | — | 72/100 (72%) | 0/100 (0%) |
| Event | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) |
|---|---|---|
| Renal FailureRenal and urinary disorders | 63/100 | 72/100 |
| deathGeneral disorders | 44/100 | 51/100 |
| Age, Categorical(Participants) | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 57 | 64 | 121 |
| >=65 years | 43 | 36 | 79 |
| Age, Continuous(years) | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | Total |
|---|---|---|---|
| Mean | 62 ± 15 | 58 ± 16 | 60 ± 15 |
| Sex: Female, Male(Participants) | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | Total |
|---|---|---|---|
| Female | 43 | 41 | 84 |
| Male | 57 | 59 | 116 |
| Region of Enrollment(participants) | Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) | Total |
|---|---|---|---|
| United States | 100 | 100 | 200 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham