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

Elderly Person Clinical Trial

— ANGIOCHOLREA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831529
• Other study ID #: PSS2017/ANGIOCHOLREA-NOVY/NK
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: February 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: January 15, 2019
• Est. primary completion date: November 14, 2018
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• > 65 years old

• ICU admission for acute cholangitis

• follow up in the same center after the ICU stay

Exclusion Criteria:

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis Infective
• Elderly Person

Locations

Country	Name	City	State
France	CHR Mercy	Metz	Lorraine
France	Emmanuel NOVY	Vandoeuvre Les Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	rate of survivors and non survivors	180 days
Secondary	mortality	rate of survivors and non survivors	90 days
Secondary	mortality	rate of survivors and non survivors	28 days
Secondary	factors associated with 6 months mortality (underlying condition)	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)	Day 1
Secondary	factors associated with 6 months mortality (severity score)	Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163	Day 1
Secondary	factors associated with 6 months mortality (Presence of hemodynamic failure)	infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not	Up to 7 days
Secondary	factors associated with 6 months mortality (Presence of respiratory failure)	number of day(s) under mechanical ventilation	Up to 7 days
Secondary	factors associated with 6 months mortality (Presence of renal failure)	number od day(s) under renal replacement therapy	Up to 7 days
Secondary	Clinical evolution	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	Day 3