NCT00948441

Brief Summary

This study is a double-blind crossover design to compare prophylaxis with ethanol lock therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number of catheter related blood stream infections (CRBSI) in each time period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 21, 2016

Completed
Last Updated

April 18, 2016

Status Verified

March 1, 2016

Enrollment Period

6.3 years

First QC Date

July 7, 2009

Results QC Date

February 19, 2016

Last Update Submit

March 18, 2016

Conditions

Catheter-Related Infections

Keywords

intestinal insufficiencycentral venous catheterCatheter-Related Infectionspediatricsethanol

Outcome Measures

Primary Outcomes (1)

  • Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.

    For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.

    7 months per study patient

Secondary Outcomes (1)

  • Safety, Side Effects

    7 months per study patient

Study Arms (2)

Group 1

EXPERIMENTAL

25% ethanol for 12 weeks; wash out period for 4 weeks; heparin lock for 12 weeks

Drug: 25% ethanolOther: heparin lock

Group 2

EXPERIMENTAL

heparin lock for 12 weeks; wash out period for 4 weeks; 25% ethanol lock for 12 weeks

Drug: 25% ethanolOther: heparin lock

Interventions

25% ethanolDRUG

Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day.

Also known as: ethanol
Group 1Group 2
heparin lockOTHER

Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours.

Group 1Group 2

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with central venous access and a history of three or more CRBSI in the prior 6 months
  • age greater than 6 months
  • anticipation for the need for continued central venous access over the next 7 months
  • availability to come for a monthly study visit
  • anticipation that the patient will receive medical care at Children's Hospital of Pittsburgh for the majority of the CRBSI which occur during the next 7 months and the ability to lock the central venous catheter for a minimum of 4 hours per day

You may not qualify if:

  • age less than 6 months and greater than or equal to 21 years
  • known immunodeficiency (with the exception of immunosuppression in a patient after organ transplantation)
  • known allergy or intolerance to ethanol or heparin lock therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15201, United States

Location

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

EthanolVascular Access Devices

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsCathetersEquipment and Supplies

Results Point of Contact

Title
Judith M. Martin, MD
Organization
University of Pittsburgh
judy.martin@chp.edu
412-692-7028

Study Officials

  • Judith M Martin, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 29, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 18, 2016

Results First Posted

March 21, 2016

Record last verified: 2016-03

Locations

US(1)