High Dose CVVHDF Compared to Standard Dose CVVHDF

NCT00561431 | Completed Phase 3 Results DMC

• 1 other identifier: X030108004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure

Keywords

CVVHDF Dose Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT

  Up to 30 days

Study Arms (2)

1

ACTIVE COMPARATOR

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

Device: Standard dose of dialysis

2

EXPERIMENTAL

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

Device: High dose of dialysis

Interventions

Standard dose of dialysis DEVICE

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

1

High dose of dialysis DEVICE

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

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pfizer: collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

• 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.

  PMID: 36416787 DERIVED

• 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.

  PMID: 34519356 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Results Point of Contact

• Title: Ashita Tolwani, M.D.
• Organization: University of Alabama at Birmingham

atolwani@uab.edu

2059752021

Study Officials

• Ashita J. Tolwani, MD

  The University of Alabama at Birmingham, Division of Nephrology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigatorl

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: July 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 14, 2015
• Results First Posted: March 12, 2010

Record last verified: 2015-03

Locations

US (1)