Clinical trial NCT03222232: Catheter Salvage in Intestinal Failure Patients
Official title: Catheter-related Bloodstream Infections in Patients With Intestinal Failure Receiving Home Parenteral Support: Risks Related to a Catheter-salvage-strategy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Failure
Catheter-Related Bloodstream Infection (CRBSI) Nos
Keywords: intestinal failure
catheter-related bloodstream infections
catheter salvage
recurrent infections
home parenteral support
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 715
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: new catheter-related bloodstream infections
timeFrame: 2002 to 2016
Secondary outcomes:
measure: recurrent catheter-related bloodstream infections
timeFrame: 2002 to 2016
measure: relapse catheter-related bloodstream infection
timeFrame: 2002 to 2016
measure: primary salvage rate
timeFrame: 2002 to 2016
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121
Study officials:
affiliation: Department of Medical gastroenterology, Rigshospitalet
name: Siri Tribler, MD
role: PRINCIPAL_INVESTIGATOR
References: