Phase 3 N=200 Randomized Treatment

High Dose CVVHDF Compared to Standard Dose CVVHDF

Acute Renal Failure

Bottom Line

View on ClinicalTrials.gov: NCT00561431 ↗

Enrolled (actual)

200

Serious AEs

67.5%

Results posted

Mar 2010

Primary outcome: Primary: Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) — 56; 49 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Standard dose of dialysis (Device); High dose of dialysis (Device)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)	56; 49	—
SECONDARY Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT	37; 28	—

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.

Eligibility Criteria

Inclusion Criteria

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 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.

Exclusion Criteria

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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Data sourced from ClinicalTrials.gov (NCT00561431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.