Trial Outcomes & Findings for Complications Associated With Central Venous Access in the NSICU: PICC vs CVC (NCT NCT02314520)
NCT ID: NCT02314520
Last Updated: 2017-07-19
Results Overview
Aggregation of all complications associated with central access including insertion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
up to 10 weeks
Results posted on
2017-07-19
Participant Flow
Participant milestones
| Measure |
PICC
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
80
|
|
Overall Study
COMPLETED
|
72
|
80
|
|
Overall Study
NOT COMPLETED
|
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 |
PICC
n=72 Participants
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
n=80 Participants
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 18 • n=72 Participants
|
63.3 years
STANDARD_DEVIATION 13.6 • n=80 Participants
|
61.4 years
STANDARD_DEVIATION 15.9 • n=152 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=72 Participants
|
35 Participants
n=80 Participants
|
72 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=72 Participants
|
45 Participants
n=80 Participants
|
80 Participants
n=152 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
72 Participants
n=72 Participants
|
80 Participants
n=80 Participants
|
152 Participants
n=152 Participants
|
|
Glasgow Coma Scale (Total)
|
9.5 points
STANDARD_DEVIATION 4.0 • n=72 Participants
|
10 points
STANDARD_DEVIATION 3.6 • n=80 Participants
|
10 points
STANDARD_DEVIATION 3.8 • n=152 Participants
|
|
Hemiparesis
|
38 Participants
n=72 Participants
|
38 Participants
n=80 Participants
|
76 Participants
n=152 Participants
|
|
Diagnosis
stroke
|
28 Participants
n=72 Participants
|
29 Participants
n=80 Participants
|
57 Participants
n=152 Participants
|
|
Diagnosis
subarachnoid hemorrhage
|
14 Participants
n=72 Participants
|
18 Participants
n=80 Participants
|
32 Participants
n=152 Participants
|
|
Diagnosis
traumatic brain injury
|
11 Participants
n=72 Participants
|
8 Participants
n=80 Participants
|
19 Participants
n=152 Participants
|
|
Diagnosis
intraparenchymal hematoma
|
10 Participants
n=72 Participants
|
12 Participants
n=80 Participants
|
22 Participants
n=152 Participants
|
|
Diagnosis
myasthenia gravis
|
0 Participants
n=72 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=152 Participants
|
|
Diagnosis
intraventricular hemorrhage
|
0 Participants
n=72 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=152 Participants
|
|
Diagnosis
other
|
9 Participants
n=72 Participants
|
11 Participants
n=80 Participants
|
20 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: up to 10 weeksAggregation of all complications associated with central access including insertion
Outcome measures
| Measure |
PICC
n=72 Participants
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
n=80 Participants
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
|---|---|---|
|
Participants With Complications With Central Access Including Insertion
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: up to 10 weeksOutcome measures
| Measure |
PICC
n=72 Participants
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
n=80 Participants
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
|---|---|---|
|
Number of Participants With Deep Venous Thrombosis
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of insertion until first confirmatory chest X-rayAny complication of insertion including technical failure
Outcome measures
| Measure |
PICC
n=72 Participants
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
n=80 Participants
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
|---|---|---|
|
Number of Patients With Complications Related to Insertion
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 10 weeksA Central access associated infection (CLABSI)
Outcome measures
| Measure |
PICC
n=72 Participants
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
n=80 Participants
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
|---|---|---|
|
Number of Participants With a Central Line Associated Blood Stream Infection
|
0 Participants
|
0 Participants
|
Adverse Events
PICC
Serious events: 4 serious events
Other events: 0 other events
Deaths: 13 deaths
Central Line
Serious events: 1 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
PICC
n=72 participants at risk
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
peripherally inserted central catheter: Any complication associated with central access
|
Central Line
n=80 participants at risk
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
centrally inserted central catheter: Central access not associated with any complication
|
|---|---|---|
|
Blood and lymphatic system disorders
Deep venous thrombosis
|
5.6%
4/72 • Number of events 4 • 19 Months
Definitions do not differ.
|
0.00%
0/80 • 19 Months
Definitions do not differ.
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.00%
0/72 • 19 Months
Definitions do not differ.
|
1.2%
1/80 • Number of events 1 • 19 Months
Definitions do not differ.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. J. Christopher Zacko
Penn State Health Milton S. Hershey Medical Center Dept of Neurosurgery
Phone: 717-531-1279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place