Trial Outcomes & Findings for Central Venous Access Study (NCT NCT03480542)
NCT ID: NCT03480542
Last Updated: 2024-06-10
Results Overview
Number of medical records with documented mechanical/technical, thrombotic, and other adverse outcomes associated with use of CVCs, PICCs, and Hemodialysis (HD) catheters.
Recruitment status
COMPLETED
Target enrollment
217 participants
Primary outcome timeframe
1 year
Results posted on
2024-06-10
Participant Flow
The number of catheters was the focus of the study and because some patients had multiple catheters places, the number of patients does not coincide with the number of catheters.
Participant milestones
| Measure |
Number of Hemodialysis Catheters
Number of patient medical records with incidence of hemodialysis catheters
|
Number of Peripherally Inserted Central Venous Catheters
Number of patient medical records with incidence of peripherally inserted central venous catheters (PICC)
|
Number of Central Venous Catheters
Number of patient medical records with incidence of central venous catheters (CVC)
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
53
|
152
|
|
Overall Study
COMPLETED
|
12
|
53
|
152
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Number of Patients Who Received Hemodialysis Catheters
n=12 Participants
Number of patients who received hemodialysis catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedure (note, patients received more than one catheter during hospitalization).
|
Number of Patients Who Received Peripherally Inserted Peripherally Inserted Central Venous Catheters
n=39 Participants
Number of patients who received Peripherally Inserted Central Venous Catheters (PICC) were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures(note, patients received more than one catheter during hospitalization).
|
Number of Patients Who Received Central Venous Catheters
n=127 Participants
Number of patients who patients who received Central Venous Catheters (CVC) were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures (note, patients received more than one catheter during hospitalization).
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
n=12 Participants
|
68 years
n=39 Participants
|
65.6 years
n=127 Participants
|
65.9 years
n=178 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=12 Participants
|
16 Participants
n=39 Participants
|
82 Participants
n=127 Participants
|
105 Participants
n=178 Participants
|
|
Sex/Gender, Customized
Female
|
5 Participants
n=12 Participants
|
23 Participants
n=39 Participants
|
45 Participants
n=127 Participants
|
73 Participants
n=178 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Medical charts of eligible patients were reviewed and the number of patient medical charts with documentation are summarized. Note, a single patient may have received multiple catheters placed during their hospitalization.
Number of medical records with documented mechanical/technical, thrombotic, and other adverse outcomes associated with use of CVCs, PICCs, and Hemodialysis (HD) catheters.
Outcome measures
| Measure |
Patients Who Received Hemodialysis Catheters
n=12 # of placed catheters
Medical records of patients who received hemodialysis catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures.
|
Patients Who Received Peripherally Inserted Central Venous Catheters (PICC)
n=53 # of placed catheters
Medical records of patients who received peripherally inserted central venous catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures.
|
Patients Who Received Central Venous Catheters (CVC)
n=152 # of placed catheters
Medical records of patients who received central venous catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures.
|
|---|---|---|---|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented Fluoroscopy
|
4 # of catheter-related incidents
|
0 # of catheter-related incidents
|
152 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented Catheter Insertion Attempts
|
12 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented Radiological Confirmation of Placement
|
11 # of catheter-related incidents
|
15 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented indications for catheter-use
|
12 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented department/unit locations for Catheter Insertion
|
8 # of catheter-related incidents
|
14 # of catheter-related incidents
|
152 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented Personnel conducting insertion
|
12 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented dressing changes
|
2 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented mask used at dressing change
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented procedures accessed for central lines
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented Scrub the hub procedures
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented Alcohol impregnated caps used
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented CUROS caps used
|
1 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented flushes with normal saline
|
11 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented flushes with heparin lock
|
12 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of documented syringe sizes used for flushing
|
3 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Medical charts of eligible patients with HD, PICC, and CVC catheters were reviewed for catheter complications
Number of medical records with documented complications associated with the use of CVCs, PICCs, and Hemodialysis (HD) catheters
Outcome measures
| Measure |
Patients Who Received Hemodialysis Catheters
n=12 Number of placed catheters
Medical records of patients who received hemodialysis catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures.
|
Patients Who Received Peripherally Inserted Central Venous Catheters (PICC)
n=53 Number of placed catheters
Medical records of patients who received peripherally inserted central venous catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures.
|
Patients Who Received Central Venous Catheters (CVC)
n=152 Number of placed catheters
Medical records of patients who received central venous catheters were reviewed for documentation of variation in practice in comparison to standard guidelines, policies and procedures.
|
|---|---|---|---|
|
Number of Documented Catheter Complications
Number of Documented Mechanical complication
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of Documented Mechanical complication type
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of Documented Infections Complication
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of Documented Infection complication type
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of Documented Thrombotic complication
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of Documented Thrombotic type
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of Documented Catheter dwell
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
0 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of documented date of Line insertion
|
12 # of catheter-related incidents
|
53 # of catheter-related incidents
|
152 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of documented time of Line insertion
|
11 # of catheter-related incidents
|
53 # of catheter-related incidents
|
152 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of documented date of Line removal
|
12 # of catheter-related incidents
|
53 # of catheter-related incidents
|
152 # of catheter-related incidents
|
|
Number of Documented Catheter Complications
Number of documented time of Line removal
|
12 # of catheter-related incidents
|
53 # of catheter-related incidents
|
152 # of catheter-related incidents
|
Adverse Events
Number of Hemodialysis Catheters
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Number of Peripherally Inserted Central Venous Catheters (PICC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Number of Central Venous Catheters (CVC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place