Trial Outcomes & Findings for Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters (NCT NCT01578993)

Last Updated: 2016-03-16

Results Overview

The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

Insertion to Removal / maximum 3 months

Results posted on

2016-03-16

Participant milestones
Measure	Single Arm Study Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters

Baseline characteristics by cohort
Measure	Single Arm Study n=101 Participants Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
Age, Continuous	55 Years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants

Timeframe: Insertion to Removal / maximum 3 months

The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.

Outcome measures
Measure	Single Arm Study n=101 Participants Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
Rate of PICC Line Occlusions	37 percentage of enrolled subjects

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Single Arm Study n=101 participants at risk Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
Blood and lymphatic system disorders Venous thrombosis	5.9% 6/101 • This observationaol study included recording of line occlusions and incidence of venous thrombosis from the time of PICC insertion until removal of the PICC line or for a maximum of 90 days.

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