Trial Outcomes & Findings for Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis (NCT NCT01590550)
NCT ID: NCT01590550
Last Updated: 2020-11-10
Results Overview
Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.
COMPLETED
18 participants
Followed until HD with Citrate dialysate is discontinued, average 3 weeks
2020-11-10
Participant Flow
Pediatric patients receiving hemodialysis (HD) at a single institution during the specified study period
Participant milestones
| Measure |
Observational
All patients receiving acute HD during the study period
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
Observational
n=18 Participants
All patients receiving acute HD during the study period
|
|---|---|
|
Age, Continuous
|
7.8 years
STANDARD_DEVIATION 6.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Followed until HD with Citrate dialysate is discontinued, average 3 weeksPopulation: 18 patients and 119 HD treatments
Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.
Outcome measures
| Measure |
Observational
n=18 Participants
All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
|
|---|---|
|
Dialyzer Clotting Rate
|
6 percentage of total treatments
|
SECONDARY outcome
Timeframe: Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeksSaline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months
Outcome measures
| Measure |
Observational
n=18 Participants
All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
|
|---|---|
|
Saline Flush Rate
|
0 percentage of hemodialysis treatments
|
SECONDARY outcome
Timeframe: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinuedThe heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months
Outcome measures
| Measure |
Observational
n=18 Participants
All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
|
|---|---|
|
Heparin Use Rate
|
0 percentage of hemodialysis treatments
|
Adverse Events
Observational
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Observational
n=18 participants at risk
All patients receiving acute HD during the study period
|
|---|---|
|
General disorders
Clotting of circuit
|
16.7%
3/18 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place