Clinical trial NCT03831529: Outcomes of Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis
Official title: Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangitis Infective
Elderly Person
Keywords: critically ill
mortality
outcome
treatment intensity level
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 204
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 65 years old admitted to the ICU for acute severe cholangitis

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: mortality
timeFrame: 180 days
Secondary outcomes:
measure: mortality
timeFrame: 90 days
measure: mortality
timeFrame: 28 days
measure: factors associated with 6 months mortality (underlying condition)
timeFrame: Day 1
measure: factors associated with 6 months mortality (severity score)
timeFrame: Day 1
measure: factors associated with 6 months mortality (Presence of hemodynamic failure)
timeFrame: Up to 7 days
measure: factors associated with 6 months mortality (Presence of respiratory failure)
timeFrame: Up to 7 days
measure: factors associated with 6 months mortality (Presence of renal failure)
timeFrame: Up to 7 days
measure: Clinical evolution
timeFrame: Day 3
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Mercy
state: Lorraine
city: Vandoeuvre Les Nancy
country: France
facility: Emmanuel NOVY
state: Lorraine
Study officials:
References:
citation: 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.