NCT02545309

Brief Summary

SSC-CIP is increasing in patients after critical illness. Pathogenesis is still largely unclear. The investigators hypothesize that genetic variants of biliary transporter genes are frequent in patients with SSC-CIP. In approximately 140 patients and controls the rate of genetic variants in biliary transporter genes, gut permeability and gut microbiome as well as bone health will be studied.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2015Jan 2028

First Submitted

Initial submission to the registry

July 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 21, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

10 years

First QC Date

July 29, 2015

Last Update Submit

March 3, 2025

Conditions

Secondary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

  • bile acid transporter genes

    Rate of genetic variants in biliary transporter genes

    Day 1

Secondary Outcomes (4)

  • gut permeability

    Day 1

  • bile acids

    Day 1

  • bone health

    Day 1

  • upper gastrointestinal bleeding episodes

    through study completion, an average of 3 years (from date of inclusion through end of observation/death)

Study Arms (2)

SSC-CIP

Patients with secondary sclerosing cholangitis in critically ill patients

control

Patients with similar degree of critical illness who do not develop secondary sclerosing cholangitis in critically ill patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with no liver disease in the past, who develop secondary sclerosing cholangitis during/after a critical illness

You may qualify if:

  • informed consent
  • Age above 18 years
  • secondary sclerosing cholangitis in critically ill patients

You may not qualify if:

  • mechanical cholestasis
  • primary sclerosing cholangitis
  • primary biliary cirrhosis
  • Immune globulin G4 associated cholangitis
  • toxic cholestasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Stool Urine DNA

Study Officials

  • Vanessa Stadlbauer, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

September 9, 2015

Study Start

December 21, 2015

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

March 4, 2025

Record last verified: 2025-03

Locations

AU(1)