Clinical trial NCT00561431: High Dose CVVHDF Compared to Standard Dose CVVHDF
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Renal Failure
Keywords: CVVHDF Dose Study
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 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.

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

Primary outcomes:
measure: Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)
timeFrame: Up to 30 days
Secondary outcomes:
measure: Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham, Division of Nephrology
name: Ashita J. Tolwani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.