ABOUT THIS STUDY
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- Male or female > or equal to 19 yrs of age
- ARF defined by at least one of the following:
- Volume overload from inadequate urine output despite diuretic agents.
- Oliguria (urine output < 200 ml/12hrs) despite fluid resuscitation and diuretic administration.
- Anuria (urine output < 50 ml/12 hrs).
- Acute azotemia (BUN > or equal to 80 mg/dl).
- Acute hyperkalemia not responsive to medication (K+ > or equal to 6.5mmol/L)
- An increase in serum creatinine of > 2.5 mg/dl from normal values or a sustained rise in serum creatinine of > or equal to 1 mg/dl over baseline.
- Patients with end stage renal disease
- Patients who have had more than one previous dialysis session for acute or chronic
renal failure during the current hospitalization
- Patient weight greater than 125 kg
- Patient weight less than 50 kg
- Pregnancy
- Prisoner
- Non-candidacy for continuous renal replacement therapy (CRRT)
- Patient/surrogate refusal
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- Birmingham, Alabama
Descriptive Information | ||||
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Brief Title ICMJE | High Dose CVVHDF Compared to Standard Dose CVVHDF | |||
Official Title ICMJE | A Randomized Prospective Study Comparing High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) to Standard Dose CVVHDF in Critically Ill Patients With Acute Renal Failure at the University of Alabama at Birmingham | |||
Brief Summary | 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. | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Acute Renal Failure | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 200 | |||
Original Actual Enrollment ICMJE | 212 | |||
Actual Study Completion Date ICMJE | November 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00561431 | |||
Other Study ID Numbers ICMJE | X030108004 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Ashita Tolwani, University of Alabama at Birmingham | |||
Study Sponsor ICMJE | University of Alabama at Birmingham | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Alabama at Birmingham | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |