NCT01409772

Brief Summary

The purpose of this study is to evaluate the clinical practice of the prophylactic use of ethanol locks for the prevention of catheter related blood stream infections in pediatric intestinal rehabilitation program patients requiring total parenteral nutrition.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2009

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

May 22, 2009

Last Update Submit

August 18, 2023

Conditions

Blood Stream InfectionsShort Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 90 day infection rate prior to enrollment

    To determine the 90 day infection rate in eligible subjects for the term immediately prior to enrollment in the study protocol.

    90 days

Secondary Outcomes (2)

  • 90 day CRBSI rate

    90 days

  • Organism and Treatment in CRBSI

    90 days

Study Arms (1)

Intestinal Rehab

Pediatric Patients Undergoing Intestinal Rehabilitation for short bowel syndrome

Drug: Ethanol Lock

Interventions

Ethanol LockDRUG

Ethanol Lock

Also known as: 70% ethanol
Intestinal Rehab

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Short Bowel Syndrome

You may qualify if:

  • Signed informed consent/assent and willingness to adhere to protocol
  • Intestinal rehabilitation patients with documented short bowel syndrome
  • Age: newborn to 19 years of age
  • Indwelling tunneled venous catheter placed for the purpose of total parenteral nutrition/IV fluids, with a 2 hour or longer window out of 24 hours for ethanol lock instillation
  • No history of alcohol abuse
  • No history of hypersensitivity to ethanol
  • No history or documented active seizure disorder

You may not qualify if:

  • Parent/guardian unwilling to sign consent
  • Active bacterial infection
  • Non-tunneled, non-permanent catheter (triple lumen or PICC)
  • Pre-existing condition that would prevent enrollment as determined by each patients' physician
  • Inability to adhere to protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Kari A Simonsen, MD

    UNMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

August 4, 2011

Study Start

May 1, 2009

Primary Completion

July 9, 2009

Study Completion

July 9, 2009

Last Updated

August 22, 2023

Record last verified: 2023-08