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

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ClinicalTrials.gov Identifier: NCT03831529
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Tracking Information
First Submitted Date January 18, 2019
First Posted Date February 6, 2019
Last Update Posted Date February 6, 2019
Actual Study Start Date June 18, 2018
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2019)
mortality [ Time Frame: 180 days ]
rate of survivors and non survivors
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 4, 2019)
  • mortality [ Time Frame: 90 days ]
    rate of survivors and non survivors
  • mortality [ Time Frame: 28 days ]
    rate of survivors and non survivors
  • 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)
  • factors associated with 6 months mortality (severity score) [ Time Frame: Day 1 ]
    Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163
  • 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
  • factors associated with 6 months mortality (Presence of respiratory failure) [ Time Frame: Up to 7 days ]
    number of day(s) under mechanical ventilation
  • factors associated with 6 months mortality (Presence of renal failure) [ Time Frame: Up to 7 days ]
    number od day(s) under renal replacement therapy
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients > 65 years old admitted to the ICU for acute severe cholangitis
Condition
  • Cholangitis Infective
  • Elderly Person
Intervention Not Provided
Study Groups/Cohorts ICU older patient
Older patient (> 65 years old) admitted to ICU with severe acute cholangitis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 4, 2019)
204
Original Actual Enrollment Same as current
Actual Study Completion Date January 15, 2019
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03831529
Other Study ID Numbers PSS2017/ANGIOCHOLREA-NOVY/NK
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators Not Provided
Investigators Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date February 2019