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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: September 21, 2016
Last verified: September 2016
Results First Received: February 2, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Complication of Dialysis
Intervention: Procedure: Use of citrate based dialysate

  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 
Overall Participants Analyzed 
[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
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1.  Primary:   Dialyzer Clotting Rate   [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued ]

2.  Secondary:   Saline Flush Rate   [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued ]

3.  Secondary:   Heparin Use Rate   [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued ]


  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