NCT02314520: NSPVC

Complications Associated With Central Venous Access in the NSICU: PICC vs CVC

Completed NA Results posted Last updated 19 July 2017

What this trial tests

NA trial testing peripherally inserted central catheter in PICC in 152 participants. Completed in 7 December 2016.

Timeline

13 July 2015

Primary endpoint
7 December 2016

7 December 2016

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	152
Start date	13 July 2015
Primary completion	7 December 2016
Estimated completion	7 December 2016
Sites	1 location across United States

Drugs / interventions tested

• peripherally inserted central catheter
• centrally inserted central catheter

Conditions studied

• PICC — all drugs for PICC →
• Central Venous Catheter — all drugs for Central Venous Catheter →
• Central Line — all drugs for Central Line →
• Neuro ICU — all drugs for Neuro ICU →

Sponsor

Milton S. Hershey Medical Center

Who can join

18 and older, any sex, with PICC or Central Venous Catheter. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Complications With Central Access Including Insertion Primary · up to 10 weeks

Aggregation of all complications associated with central access including insertion

Group	Value	95% CI
PICC	14
Central Line	10

Number of Participants With Deep Venous Thrombosis Secondary · up to 10 weeks

Group	Value	95% CI
PICC	4
Central Line	0

Number of Patients With Complications Related to Insertion Secondary · From the time of insertion until first confirmatory chest X-ray

Any complication of insertion including technical failure

Group	Value	95% CI
PICC	8
Central Line	6

Number of Participants With a Central Line Associated Blood Stream Infection Secondary · up to 10 weeks

A Central access associated infection (CLABSI)

Group	Value	95% CI
PICC	0
Central Line	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 19 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PICC

Serious: 4/72 (6%)

Deaths: 13/72

Central Line

Serious: 1/80 (1%)

Deaths: 9/80

Serious adverse events (2 terms)

Reaction	System	PICC	Central Line
Deep venous thrombosis	Blood and lymphatic system disorders	—	—
Pneumothorax	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Deep venous thrombosis, Pneumothorax.

Data from ClinicalTrials.gov NCT02314520 adverse events section.

Sponsor's own description

The goal of this study is to determine whether Peripherally Inserted Central Catheter or Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience Intensive Care Unit. After admission to the Neuroscience ICU and if they require central access, patients will be randomized to receive a PICC or CVC and complications (such as pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between the two interventions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.