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NCT Number: NCT03831529

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

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Mercy, Metz, Lorraine, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 180 days

    rate of survivors and non survivors

Secondary outcomes

  1. mortality

    Time frame: 90 days

    rate of survivors and non survivors

  2. mortality

    Time frame: 28 days

    rate of survivors and non survivors

  3. factors associated with 6 months mortality (underlying condition)

    Time frame: 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)

  4. factors associated with 6 months mortality (severity score)

    Time frame: Day 1

    Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163

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

    Time frame: Up to 7 days

    infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not

  6. factors associated with 6 months mortality (Presence of respiratory failure)

    Time frame: Up to 7 days

    number of day(s) under mechanical ventilation

  7. factors associated with 6 months mortality (Presence of renal failure)

    Time frame: Up to 7 days

    number od day(s) under renal replacement therapy

  8. Clinical evolution

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis

Acronym: ANGIOCHOLREA

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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