NCT03831529

Brief Summary

The aging of the population goes along with an increased demand for intensive care among very elderly patients (above 75-80 years old). At the same time, there is a decline in the supply of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor quality of life, cognitive impairment and functional disability. It is unclear under what conditions older patients may benefit from ICU admission. Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a potentially life threatening disease characterized by a biliary obstruction and an infection of the bile possibly evolving towards systemic infection, shock and death. Because of its potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary decompression with drainage, old patients suffering from acute cholangitis are easily admitted to intensive care unit. To date, there is a lack of data about the outcome in this population admitted to the intensive care unit with acute cholangitis. The aim of the current study is to describe the outcomes in elderly patients (\> 75 years old) admitted to the ICU with acute cholangitis and to identify prognostics factors associated with long term mortality (6 months).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

June 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

January 18, 2019

Last Update Submit

February 4, 2019

Conditions

Keywords

critically illmortalityoutcometreatment intensity level

Outcome Measures

Primary Outcomes (1)

  • mortality

    rate of survivors and non survivors

    180 days

Secondary Outcomes (8)

  • mortality

    90 days

  • mortality

    28 days

  • factors associated with 6 months mortality (underlying condition)

    Day 1

  • factors associated with 6 months mortality (severity score)

    Day 1

  • factors associated with 6 months mortality (Presence of hemodynamic failure)

    Up to 7 days

  • +3 more secondary outcomes

Study Arms (1)

ICU older patient

Older patient (\> 65 years old) admitted to ICU with severe acute cholangitis

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \> 65 years old admitted to the ICU for acute severe cholangitis

You may qualify if:

  • \> 65 years old
  • ICU admission for acute cholangitis
  • follow up in the same center after the ICU stay

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHR Mercy

Metz, Lorraine, 57000, France

Location

Emmanuel NOVY

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Related Publications (1)

  • Novy E, Carrara L, Remen T, Chevaux JB, Losser MR, Louis G, Guerci P. Prognostic factors associated with six month mortality of critically ill elderly patients admitted to the intensive care unit with severe acute cholangitis. HPB (Oxford). 2021 Mar;23(3):459-467. doi: 10.1016/j.hpb.2020.08.003. Epub 2020 Aug 22.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

February 6, 2019

Study Start

June 18, 2018

Primary Completion

November 14, 2018

Study Completion

January 15, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations