High Dose CVVHDF Compared to Standard Dose CVVHDF

NCT00561431

Last updated date
Study Location
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Renal Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Acute Renal FailureHigh Dose CVVHDF Compared to Standard Dose CVVHDF
NCT00561431
  1. Birmingham, Alabama
ALL GENDERS
19 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE High Dose CVVHDF Compared to Standard Dose CVVHDF
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Renal Failure
Intervention  ICMJE
  • Device: Standard dose of dialysis
    Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr
  • Device: High dose of dialysis
    Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr
Study Arms  ICMJE
  • Active Comparator: 1
    Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
    Intervention: Device: Standard dose of dialysis
  • Experimental: 2
    High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
    Intervention: Device: High dose of dialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2010)
200
Original Actual Enrollment  ICMJE
 (submitted: November 20, 2007)
212
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00561431
Other Study ID Numbers  ICMJE X030108004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ashita Tolwani, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Ashita J. Tolwani, MDThe University of Alabama at Birmingham, Division of Nephrology
PRS Account University of Alabama at Birmingham
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP