High Dose CVVHDF Compared to Standard Dose CVVHDF

Acute Renal Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561431
• Other study ID #: X030108004
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2007
• Last updated: March 24, 2015
• Start date: July 2003
• Est. completion date: November 2007

Study information

• Verified date: March 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Device:
• Standard dose of dialysis
Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
• High dose of dialysis
Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)	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.	Up to 30 days	No
Secondary	Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT	The number of participants who recover renal function at 30 days after enrollment in each arm.	Up to 30 days	No