Cholangitis InfectiveANGIOCHOLREANCT03831529
Outcomes of Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis
An observational study of Cholangitis Infective and Elderly Person, run by Central Hospital, Nancy, France at 2 sites in France.
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%. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cholangitis Infective, Elderly Person
- How many people
- 204 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jun 2018to 15 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: Patients > 65 years old admitted to the ICU for acute severe cholangitis
Who may be able to join
- > 65 years old
- ICU admission for acute cholangitis
- follow up in the same center after the ICU stay
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHR Mercy
Metz, Lorraine, 57000
Emmanuel NOVY
Vandœuvre-lès-Nancy, Lorraine, 54500
About this study
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
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.
Read more
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).
- Conditions
- Cholangitis Infective, Elderly Person
- Keywords
- critically ill, mortality, outcome, treatment intensity level
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU older patient | Older patient (> 65 years old) admitted to ICU with severe acute cholangitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
rate of survivors and non survivors
Measured: 180 days
Secondary outcomes (8)
mortality
rate of survivors and non survivors
Measured: 90 days
mortality
rate of survivors and non survivors
Measured: 28 days
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)
Measured: Day 1
factors associated with 6 months mortality (severity score)
Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163
Measured: Day 1
factors associated with 6 months mortality (Presence of hemodynamic failure)
infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not
Measured: Up to 7 days
factors associated with 6 months mortality (Presence of respiratory failure)
number of day(s) under mechanical ventilation
Measured: Up to 7 days
factors associated with 6 months mortality (Presence of renal failure)
number od day(s) under renal replacement therapy
Measured: Up to 7 days
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
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start18 Jun 2018
- Primary completion14 Nov 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangitis InfectiveStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831529
- Sponsor's protocol ID
- PSS2017/ANGIOCHOLREA-NOVY/NK
- Acronym
- ANGIOCHOLREA
- Status last verified
- Feb 2019
- First submitted
- 18 Jan 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32839088
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03831529
- Acronym / sponsor ID
- ANGIOCHOLREA / PSS2017/ANGIOCHOLREA-NOVY/NK
- Conditions
- Cholangitis Infective, Elderly Person
- Keywords
- critically ill, mortality, outcome, treatment intensity level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU older patient | – | –Older patient (> 65 years old) admitted to ICU with severe acute cholangitis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients > 65 years old admitted to the ICU for acute severe cholangitis
Key inclusion criteria (3 listed)
- > 65 years old
- ICU admission for acute cholangitis
- follow up in the same center after the ICU stay
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 180 days
rate of survivors and non survivors
8 secondary outcomes
mortality
Time frame: 90 days
mortality
Time frame: 28 days
factors associated with 6 months mortality (underlying condition)
Time frame: Day 1
factors associated with 6 months mortality (severity score)
Time frame: Day 1
factors associated with 6 months mortality (Presence of hemodynamic failure)
Time frame: Up to 7 days
factors associated with 6 months mortality (Presence of respiratory failure)
Time frame: Up to 7 days
factors associated with 6 months mortality (Presence of renal failure)
Time frame: Up to 7 days
Clinical evolution
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Derived from this study: PubMed 32839088Novy 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangitis Infective and Elderly Person, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03831529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.