Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rita Sheth, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01590550
First received: April 29, 2012
Last updated: February 2, 2016
Last verified: February 2016
Results First Received: February 2, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Complication 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
Pediatric patients receiving HD at a single institution during the specified study period

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
Observational All patients receiving acute HD during the study period

Participant Flow:   Overall Study
    Observational  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Observational All patients receiving acute HD during the study period

Baseline Measures
    Observational  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean (Standard Deviation)
  7.8  (6.7)  
Gender  
[units: participants]
 
Female     8  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures

1.  Primary:   Dialyzer Clotting Rate   [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued, an expected average of 4 weeks ]

2.  Secondary:   Saline Flush Rate   [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued, an expected average of 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Heparin Use Rate   [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued, an expected average of 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No control group