High Dose CVVHDF Compared to Standard Dose CVVHDF

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3

Conditions: Acute Renal Failure

Treatments: Device: High dose of dialysis; Device: Standard dose of dialysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00561431

X030108004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1

Active Comparator group

Description:

Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr

Treatment:

Device: Standard dose of dialysis

2

Experimental group

Description:

High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr

Treatment:

Device: High dose of dialysis