Efficacy and Safety of Ethanol Lock Therapy for the Preve... | NCT02890875

Studies
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections

NCT02890875

Sponsor

Stanford University

Status

Terminated

Last Update Posted

May 2, 2019Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Catheter-Related Infections

Interventions

Ethanol lock
Heparin lock

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Aug 31, 2016

First Posted Date

Sep 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2019

Last Update Posted Date

May 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ethanol lock	Active Comparator	70% ethanol	Other: Ethanol lock
Heparin lock	Active Comparator	Heparinized saline (100 U/mL)	Other: Heparin lock

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethanol lock	Other		Ethanol lock
Heparin lock

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central line-associated bloodstream infection		12 months

Secondary Outcomes

Measure	Description	Time Frame
Hospitalization		12 months
SIRS/sepsis		12 months
Catheter-related complication

Other Outcomes

Measure	Description	Time Frame
Microorganism (blood culture, if obtained for clinical reasons)		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (ages 18-80) on PN with silicone-based central venous catheters

Exclusion Criteria:

Weight ≤ 50 kg
Allergy/hypersensitivity/intolerance to ethanol or heparin
Pregnancy or breastfeeding
Patient taking metronidazole, disulfiram, or isoniazid
History of alcohol abuse
History of heparin-induced thrombocytopenia (HIT) or have an active hypocoagulable state

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Berkeley Limketkai, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	94304	United States

Condition Browse Module

MeSH Terms

ID	Term
D055499	Catheter-Related Infections
D006963	Hyperphagia

Ancestor Terms

ID	Term
D007239	Infections
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062666	Vascular Access Devices

Ancestor Terms

ID	Term
D057785	Catheters
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided