Central Line CathetersCASCADENCT03480542

Central Venous Access Study

An observational study of Central Line Catheters, run by Hackensack Meridian Health at 1 site in United States.

Completed

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

Trial summary

The aim of this study is to document clinicians variation in practice in comparison to standard guidelines by the Medical Center's approved Evidence-based Practice (EBP) guidelines, policies, and procedures for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD catheters… Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Central Line Catheters
How many people: 217 participants
Where: 1 siteUnited States
Study dates: 11 Apr 2017to 7 Apr 2022
Phase: Observational
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Three hundred patient electronic medical records will be reviewed from the Critical Care Units (Medical Intensive Care Unit, Coronary Care Unit, Cardiac Surgical Intensive Care Unit, Surgical Intensive Care Unit).

Who may be able to join

Adult patients in Medical Intensive Care Unit (MICU), Coronary Care Unit (CCU), Cardiac Surgical Intensive Care Unit (CSICU), Surgical Intensive Care Unit (SICU) with either CVCs, PICCs, or HD catheters.

Who cannot join

Pediatric (including neonates), obstetric and gynecology, medical-surgical, and oncology patients.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hackensack University Medical Center
Hackensack, New Jersey, 07601

Other trials in United States

About this study

Official title: The CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study

Read the detailed description

This will be a single site retrospective (non-experimental) study utilizing the electronic medical record, both descriptive and correlational methods.

There will be two outcomes:

The outcomes associated with the management of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter in adherence with hospital approved Evidence-based Practice guidelines for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.
The mechanical/technical, thrombotic, and other adverse outcomes (Heparin induced coagulopathy) associated with central venous catheters due to variation in insertion and management practices of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.

Conditions: Central Line Catheters

What is being measured

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

Adherence to Clinical Guidelines for Catheter Interventions and Management
Number of medical records with documented mechanical/technical, thrombotic, and other adverse outcomes associated with use of CVCs, PICCs, and Hemodialysis (HD) catheters.
Measured: 1 year

Secondary outcomes (1)

Number of Documented Catheter Complications
Number of medical records with documented complications associated with the use of CVCs, PICCs, and Hemodialysis (HD) catheters
Measured: 1 year

Timeline

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

11 Apr 20177 Apr 2022

First posted29 Mar 2018
Study start11 Apr 2017
Primary completion7 Apr 2022
Study completion7 Apr 2022

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 Central Line CathetersStudies of the same condition, open and under way.
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: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03480542
Sponsor's protocol ID: PRO2016-0711
Acronym: CASCADE
Status last verified: Dec 2023
First submitted: 21 Mar 2018
Last updated: 10 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: . If the results of the trial are published, participants' identities will remain confidential. Publication resulting from this research will not contain any information that could potentially identify participants either directly or indirectly.

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

RecruitingObservational study
Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients
Frailty, Cardiac Surgery
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
Neonatal Infection
Recruiting
SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO
Acute Ischemic Stroke
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
RecruitingPhase 3
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
Central Line Associated Blood Stream Infections (CLABSI)

All Central Line Catheters trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study
ClinicalTrials.gov ID: NCT03480542
Acronym / sponsor ID: CASCADE / PRO2016-0711
Conditions: Central Line Catheters
Study type: Observational
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Hackensack Meridian HealthUniversity, hospital or other
Study start: 11 Apr 2017 (actual)
Primary completion: 7 Apr 2022 (actual)
Study completion: 7 Apr 2022 (actual)
First posted: 29 Mar 2018 (actual)
Results: Posted 10 Jun 2024

Clinical summary

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

Detailed description

This will be a single site retrospective (non-experimental) study utilizing the electronic medical record, both descriptive and correlational methods.

There will be two outcomes:

The outcomes associated with the management of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter in adherence with hospital approved Evidence-based Practice guidelines for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.
The mechanical/technical, thrombotic, and other adverse outcomes (Heparin induced coagulopathy) associated with central venous catheters due to variation in insertion and management practices of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Three hundred patient electronic medical records will be reviewed from the Critical Care Units (Medical Intensive Care Unit, Coronary Care Unit, Cardiac Surgical Intensive Care Unit, Surgical Intensive Care Unit).

Key inclusion criteria (1 listed)

Adult patients in Medical Intensive Care Unit (MICU), Coronary Care Unit (CCU), Cardiac Surgical Intensive Care Unit (CSICU), Surgical Intensive Care Unit (SICU) with either CVCs, PICCs, or HD catheters.

Key exclusion criteria (1 listed)

Pediatric (including neonates), obstetric and gynecology, medical-surgical, and oncology patients.

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

Primary outcome

Adherence to Clinical Guidelines for Catheter Interventions and Management
Time frame: 1 year
Number of medical records with documented mechanical/technical, thrombotic, and other adverse outcomes associated with use of CVCs, PICCs, and Hemodialysis (HD) catheters.

1 secondary outcome

Number of Documented Catheter Complications
Time frame: 1 year

Results and safety

Results posted to the registry on 10 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Number of Hemodialysis Catheters	12	12
Number of Peripherally Inserted Central Venous Catheters	53	53
Number of Central Venous Catheters	152	152

Primary outcome: Adherence to Clinical Guidelines for Catheter Interventions and Management

Time frame: 1 year. Number. Unit: # of catheter-related incidents

Measure	Patients Who Received Hemodialysis Catheters n = 12	Patients Who Received Peripherally Inserted Central Venous Catheters (PICC) n = 39	Patients Who Received Central Venous Catheters (CVC) n = 127
Number of documented Catheter Insertion Attempts	12	0	0
Number of documented Radiological Confirmation of Placement	11	15	0
Number of documented Fluoroscopy	4	0	152
Number of documented indications for catheter-use	12	0	0
Number of documented department/unit locations for Catheter Insertion	8	14	152
Number of documented Personnel conducting insertion	12	0	0
Number of documented dressing changes	2	0	0
Number of documented mask used at dressing change	0	0	0

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This study collected retrospective data from patient medical charts specific to catheter complications within primary and secondary outcomes and results. Consequently, no further adverse events were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Number of Hemodialysis Catheters	0 of 0	0 of 0
Number of Peripherally Inserted Central Venous Catheters (PICC)	0 of 0	0 of 0
Number of Central Venous Catheters (CVC)	0 of 0	0 of 0

Limitations and caveats (from the sponsor): This study is an observational retrospective study with no intervention. 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. . If the results of the trial are published, participants' identities will remain confidential. Publication resulting from this research will not contain any information that could potentially identify participants either directly or indirectly.

Related trials for Central Line Catheters

RecruitingObservational study
Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients
Frailty, Cardiac Surgery
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
Neonatal Infection
Recruiting
SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO
Acute Ischemic Stroke
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
RecruitingPhase 3
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
Central Line Associated Blood Stream Infections (CLABSI)

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.

Claudia Douglas, DNP principal investigator

Hackensack Meridian Health

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

Questions about this trial

What is this clinical trial studying?

An observational study of Central Line Catheters, run by Hackensack Meridian Health at 1 site in United States.

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 1 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 10 Jun 2024. 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 10 Jun 2024). 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?

Adherence to Clinical Guidelines for Catheter Interventions and Management (time frame: 1 year). 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 NCT03480542.

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 10 Jun 2024.