Catheter Salvage in Intestinal Failure Patients

NCT03222232 | Completed

• 1 other identifier: CVC salvage study
• Study Type: observational
• Target: 715
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Failure; Catheter-Related Bloodstream Infection (CRBSI) Nos

Keywords

intestinal failure; catheter-related bloodstream infections; catheter salvage; recurrent infections; home parenteral support

Outcome Measures

Primary Outcomes (1)

• new catheter-related bloodstream infections

  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 Outcomes (3)

• recurrent catheter-related bloodstream infections

  2002 to 2016

• relapse catheter-related bloodstream infection

  2002 to 2016

• primary salvage rate

  2002 to 2016

Study Arms (1)

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

Interventions

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

chronic intestinal failure patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Never discharged on home parenteral support

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Intestinal Failure; Pyloric Stenosis, Hypertrophic; Reinfection

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Siri Tribler, MD

  Department of Medical gastroenterology, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 19, 2017
• Study Start: January 1, 2002
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: July 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)