Acute Renal Failure Trial Network (ATN) Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00076219
First received: January 15, 2004
Last updated: August 16, 2013
Last verified: August 2013
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Renal Failure
Intervention: Procedure: renal replacement therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intensive Renal Replacement Therapy In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
Less-intensive Renal Replacement Therapy In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.

Participant Flow:   Overall Study
    Intensive Renal Replacement Therapy     Less-intensive Renal Replacement Therapy  
STARTED     563     561  
COMPLETED     545     550  
NOT COMPLETED     18     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intensive Renal Replacement Therapy In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
Less-intensive Renal Replacement Therapy In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
Total Total of all reporting groups

Baseline Measures
    Intensive Renal Replacement Therapy     Less-intensive Renal Replacement Therapy     Total  
Number of Participants  
[units: participants]
  563     561     1124  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     341     335     676  
>=65 years     222     226     448  
Age  
[units: years]
Mean ± Standard Deviation
  59.6  ± 15.3     59.7  ± 15.2     59.7  ± 15.3  
Gender [1]
[units: participants]
     
Female     154     176     330  
Male     409     384     793  
[1] One subject has missing gender.



  Outcome Measures

1.  Primary:   60-day All-cause Mortality   [ Time Frame: 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Paul M. Palevsky MD
Organization: VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, PA
phone: 410-360-3932
e-mail: paul.palevsky@va.gov


Publications of Results:


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00076219     History of Changes
Other Study ID Numbers: 530
Study First Received: January 15, 2004
Results First Received: June 12, 2013
Last Updated: August 16, 2013
Health Authority: United States: Federal Government