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NCT00561431 · ClinicalTrials.gov registry record · Phase 3
High Dose CVVHDF Compared to Standard Dose CVVHDF
A Phase 3 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT00561431: Completed Phase 3 study, sponsored by University of Alabama at Birmingham.
NCT00561431 is a Phase 3 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00561431, a Phase 3 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Standard dose of dialysis
- DEVICE High dose of dialysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2003-07 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00561431 record still lists
NCT00561431 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard dose of dialysis is the first listed.
NCT00561431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00561431 about?
NCT00561431 is a clinical study titled "High Dose CVVHDF Compared to Standard Dose CVVHDF". 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 ultrafiltra...
What is the current status of trial NCT00561431?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2003-07. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00561431?
The interventions under investigation include: Standard dose of dialysis (DEVICE), High dose of dialysis (DEVICE).
Who is sponsoring clinical trial NCT00561431?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00561431's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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