PICCNSPVCNCT02314520

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

A study testing peripherally inserted central catheter and centrally inserted central catheter in people with PICC and Central Venous Catheter, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: PICC, Central Venous Catheter, Central Line
What is being tested?: peripherally inserted central catheter and centrally inserted central catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteUnited States
Study dates: 13 Jul 2015to 7 Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients admitted to the NSICU, who require central access for the treatment of their illness.

Who cannot join

Current or recent (within 1 month) diagnosis of bacteremia
Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis
Existing central access
Non-English speaking
Requirement for emergent central access and unable to obtain consent in an emergency setting

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Conditions: PICC, Central Venous Catheter, Central Line, Neuro ICU, Neuroscience ICU, CVC
Being tested: peripherally inserted central catheter, centrally inserted central catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

peripherally inserted central catheterDevice
Any complication associated with central access
centrally inserted central catheterDevice
Central access not associated with any complication

Study groups in NCT02314520
Study group	Role	What they receive
PICC	Active comparator	Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication. Receives: Device: peripherally inserted central catheter
CVC	Active comparator	Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication. Receives: Device: centrally inserted central catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants With Complications With Central Access Including Insertion
Aggregation of all complications associated with central access including insertion
Measured: up to 10 weeks

Secondary outcomes (3)

Number of Participants With Deep Venous Thrombosis
Measured: up to 10 weeks
Number of Patients With Complications Related to Insertion
Any complication of insertion including technical failure
Measured: From the time of insertion until first confirmatory chest X-ray
Number of Participants With a Central Line Associated Blood Stream Infection
A Central access associated infection (CLABSI)
Measured: up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 20157 Dec 2016

First posted11 Dec 2014 (estimated)
Study start13 Jul 2015
Primary completion7 Dec 2016
Study completion7 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PICCStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314520
Sponsor's protocol ID: STUDY00000582
Acronym: NSPVC
Status last verified: Jun 2017
First submitted: 26 Nov 2014
Last updated: 19 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Construction and Multicenter External Validation of an Early Warning Model for Asymptomatic PICC-related Upper Extremity Venous Thrombosis in Cancer Patients Based on LASSO-XGBoost
PICC-associated Thrombosis
Enrolling by invitation
Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Deep Vein Thrombosis
RecruitingPhase 3
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Reduction of Complications Associated With Extraluminal PICC Management.
Treatment (ProudMe), Vascular Access

All PICC trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complications Associated With Central Venous Access in the NSICU: PICC vs CVC
ClinicalTrials.gov ID: NCT02314520
Acronym / sponsor ID: NSPVC / STUDY00000582
Conditions: PICC, Central Venous Catheter, Central Line, Neuro ICU, Neuroscience ICU, CVC
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Study start: 13 Jul 2015 (actual)
Primary completion: 7 Dec 2016 (actual)
Study completion: 7 Dec 2016 (actual)
First posted: 11 Dec 2014 (estimated)
Results: Posted 19 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PICC	Active comparator	Device: peripherally inserted central catheterPatients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
CVC	Active comparator	Device: centrally inserted central catheterPatients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients admitted to the NSICU, who require central access for the treatment of their illness.

Key exclusion criteria (5 listed)

Current or recent (within 1 month) diagnosis of bacteremia
Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis
Existing central access
Non-English speaking
Requirement for emergent central access and unable to obtain consent in an emergency setting

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
peripherally inserted central catheterAny complication associated with central access	Device	PICC
centrally inserted central catheterCentral access not associated with any complication	Device	CVC

Primary outcome

Participants With Complications With Central Access Including Insertion
Time frame: up to 10 weeks
Aggregation of all complications associated with central access including insertion

3 secondary outcomes

Number of Participants With Deep Venous Thrombosis
Time frame: up to 10 weeks
Number of Patients With Complications Related to Insertion
Time frame: From the time of insertion until first confirmatory chest X-ray
Number of Participants With a Central Line Associated Blood Stream Infection
Time frame: up to 10 weeks

Results and safety

Results posted to the registry on 19 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PICC	72	72
Central Line	80	80

Primary outcome: Participants With Complications With Central Access Including Insertion

Time frame: up to 10 weeks. Count of participants. Unit: Participants

Measure	PICC n = 72	Central Line n = 80
Value	14	10

PICC vs Central Line: p = 0.271, Fisher Exact

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 19 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PICC	4 of 72 (5.6%)	0 of 72 (0%)	13 of 72
Central Line	1 of 80 (1.3%)	0 of 80 (0%)	9 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for PICC

Not yet recruitingObservational study
Construction and Multicenter External Validation of an Early Warning Model for Asymptomatic PICC-related Upper Extremity Venous Thrombosis in Cancer Patients Based on LASSO-XGBoost
PICC-associated Thrombosis
Enrolling by invitation
Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Deep Vein Thrombosis
RecruitingPhase 3
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Reduction of Complications Associated With Extraluminal PICC Management.
Treatment (ProudMe), Vascular Access

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Complications With Central Access Including Insertion (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02314520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.