Outcomes of Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis

Completed

• Conditions: Elderly Person; Cholangitis Infective

• Registration Number: NCT03831529
• Lead Sponsor: Central Hospital, Nancy, France

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-18
• Primary Completion: 2018-11-14
• Study Completion: 2019-01-15
• Study First Submitted: 2019-01-18
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality	180 days	rate of survivors and non survivors

Secondary Outcome Measures

Name	Time	Method
mortality	28 days	rate of survivors and non survivors
factors associated with 6 months mortality (underlying condition)	Day 1	Functional status : presence or absence of denutrition defined by a BMI \< 19 kg/m2 and/or albuminemia \< 30 g/l and/or loss of weight \> 5% during the last month (or \> 10% during the last three months)
factors associated with 6 months mortality (severity score)	Day 1	Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163
factors associated with 6 months mortality (Presence of hemodynamic failure)	Up to 7 days	infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not
factors associated with 6 months mortality (Presence of respiratory failure)	Up to 7 days	number of day(s) under mechanical ventilation
factors associated with 6 months mortality (Presence of renal failure)	Up to 7 days	number od day(s) under renal replacement therapy
Clinical evolution	Day 3	Change in Sequential Organ Failure score between Day 1 and Day 3. We measured the Sepsis-related Organ Failure Assessment (SOFA) score at day and day 3 and then made the difference between the two scores the SOFA score could range between 0 and 24 We calculated the score at day 1 and day 3 and made the difference An absence or a small difference between the 2 days is associated with a worse outcome

Trial Locations

Locations (2)

Emmanuel NOVY; 🇫🇷 Vandoeuvre Les Nancy, Lorraine, France

CHR Mercy; 🇫🇷 Metz, Lorraine, France