High Dose CVVHDF Compared to Standard Dose CVVHDF

NCT ID: NCT00561431

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2007-11-30

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.

Conditions

Acute Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Standard dose of dialysis

Intervention Type: DEVICE

Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr

2

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

Group Type: EXPERIMENTAL

High dose of dialysis

Intervention Type: DEVICE

Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr

Interventions

Standard dose of dialysis

Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr

Intervention Type: DEVICE

High dose of dialysis

Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ashita Tolwani

Principal Investigatorl

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashita J. Tolwani, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham, Division of Nephrology

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

Reference Type: DERIVED

PMID: 36416787 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34519356 (View on PubMed)

Other Identifiers

X030108004

Identifier Type: -

Identifier Source: org_study_id