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Completed

NCT Number: NCT03222232

Catheter Salvage in Intestinal Failure Patients

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.

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Key information

Conditions

Intestinal Failure Catheter-related Bloodstream Infection (CRBSI) Nos Digestive System Diseases Disease Attributes Gastric Outlet Obstruction Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pyloric Stenosis Pyloric Stenosis, Hypertrophic Recurrence Reinfection Stomach Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catheter salvage

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2015
Study completion
2015
First posted
Jul 19, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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