Catheter Salvage in Intestinal Failure Patients

July 16, 2017 updated by: Palle Bekker Jeppesen, Rigshospitalet, Denmark

Catheter-related Bloodstream Infections in Patients With Intestinal Failure Receiving Home Parenteral Support: Risks Related to a Catheter-salvage-strategy.

This is an observational study evaluating a catheter salvage strategy in relation to catheter-related bloodstream infections in patients with chronic intestinal failure dependent on home parenteral support. The study is confined to the period 2002 to 2016.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In chronic intestinal failure patients receiving home parenteral support (HPS), catheter-related bloodstream infections (CRBSIs) frequently results in replacement of their tunneled central venous catheters (CVCs) which may lead to future loss of central venous access.

This observational study investigates the consequences of a catheter-salvage-strategy related to CRBSIs according to different causative microorganisms, and short- and long-term risk of recurrence of the CRBSI. The study is based on the Copenhagen Intestinal failure database, which is a web-based database with retrospective data collection performed by reviews of medical charts from all adult intestinal failure patients discharged with home parenteral support from the Department of Medical Gastroenterology, Rigshospitalet.

Study Type

Observational

Enrollment (Actual)

715

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with intestinal failure, characterised by a reduction in the guts capacity to absorb macronutrients and/or fluid and electrolytes below what is necessary to maintain health, and therefore parenteral support (nutrition and/or fluids and electrolytes) is required to sustain life. Patient initiated on Home parenteral support was entered into the Copenhagen Intestinal failure database, and thereby eligible in this cohorte study.

Description

Inclusion Criteria:

  • chronic intestinal failure dependent on home parenteral support and enrolled in the Copenhagen Intestinal failure database

Exclusion Criteria:

  • Never discharged on home parenteral support

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic intestinal failure patients
Patients with chronic intestinal failure on home parenteral support and enrolled in the Copenhagen Intestinal failure database between January 1, 2002 and December 31, 2015.
Behavioral: catheter salvage
In each case of catheter-related bloodstream infection the management of the central venous catheter was registred to evaluate the future risk of new infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new catheter-related bloodstream infections
Time Frame: 2002 to 2016
The occurrence of catheter-related bloodstream infection after either catheter salvaged (retained central venous catheter) or replaced central venous catheter (new central venous catheter)
2002 to 2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent catheter-related bloodstream infections
Time Frame: 2002 to 2016
A recurrent infection was defined as a CRBSI with identical microorganism and antibiogram occurring within 100 days of the previous CRBSI in a salvaged CVC.
2002 to 2016
relapse catheter-related bloodstream infection
Time Frame: 2002 to 2016
A relapse infection was defined as recrudescence of the same causative microorganisms with identical antibiogram within 30 days of the previous CRBSI in a salvaged CVC.
2002 to 2016
primary salvage rate
Time Frame: 2002 to 2016
The primary salvage rate was defined by the CVC status at hospital discharge. Because of the database setup and retrospective design of the study, all cases were included regardless of main reason to CVC removal (e.g. septic shock, severe sepsis, concomitant CVC problems and secondary or metastatic complications).
2002 to 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Siri Tribler, MD, Department of Medical gastroenterology, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2002

Primary Completion (ACTUAL)

December 31, 2015

Study Completion (ACTUAL)

December 31, 2015

Study Registration Dates

First Submitted

July 16, 2017

First Submitted That Met QC Criteria

July 16, 2017

First Posted (ACTUAL)

July 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 16, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVC salvage study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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