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High Dose CVVHDF Compared to Standard Dose CVVHDF

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00561431
First received: November 19, 2007
Last updated: February 24, 2010
Last verified: February 2010
History of Changes
Results First Received: November 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Renal Failure
Interventions: Device: Standard dose of dialysis
Device: High dose of dialysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr

Participant Flow:   Overall Study
    Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)     High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)  
STARTED     100     100  
COMPLETED     100     100  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
Total Total of all reporting groups

Baseline Measures
    Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)     High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)     Total  
Number of Participants  
[units: participants]
 		  100     100     200  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     57     64     121  
>=65 years     43     36     79  
Age  
[units: years]
Mean ± Standard Deviation 		  62  ± 15     58  ± 16     60  ± 15  
Gender  
[units: participants]
 		     
Female     43     41     84  
Male     57     59     116  
Region of Enrollment  
[units: participants]
 		     
United States     100     100     200  



  Outcome Measures
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1.  Primary:   Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)   [ Time Frame: Up to 30 days ]
  Show Outcome Measure 1

2.  Secondary:   Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT   [ Time Frame: Up to 30 days ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Ashita Tolwani, M.D.
Organization: University of Alabama at Birmingham
phone: 2059752021
e-mail: atolwani@uab.edu


No publications provided


Responsible Party: Ashita Tolwani M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00561431     History of Changes
Other Study ID Numbers: X030108004
Study First Received: November 19, 2007
Results First Received: November 11, 2009
Last Updated: February 24, 2010
Health Authority: United States: Institutional Review Board