Septic ShockNCT03987048
Cirrhotic Patients With Septic Shock
An observational study of Septic Shock and Cirrhosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Cirrhosis
- What is being tested?
- Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis who require ICU admission for septic shock
Who may be able to join
- age 18 or older
- diagnosis of cirrhosis
- diagnosis of septic shock at ICU admission
Who cannot join
- prior liver transplantation
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)
Lyon, 69003
About this study
Official title: Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome
Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.
- Conditions
- Septic Shock, Cirrhosis
- Being tested
- Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.
- Medical subject headings
- Shock, Septic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.Other
Data were collected regarding medical background, medical condition and management, both at admission and during the ICU stay. These included demographics, clinical, biological and therapeutic data.
Outcome at ICU discharge and at one year were also recorded.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients with septic shock | All consecutive adult cirrhotic patients admitted to the ICU with septic shock from 2002 to 2013. Receives: Other: Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome: analysis of independent predictors of ICU mortality rate.
The predictors assessed independently are the clinical data, site of infection, biological data, liver scoring systems, organ failure, organ support and simplified acute physiology score (SAPS II), expressed in percentage of patients.
The mortality rate is expressed in percentage of patients.
Measured: Between ICU admission (from January 2002 to December 2013) and ICU discharge
Long-term outcome: analysis of independent predictors of one-year mortality rate.
The predictors assessed independently are the independent predictors found to be related to the short-term mortality rate, expressed in percentage of patients.
The mortality rate is expressed in percentage of patients.
Measured: At one year after ICU admission (from January 2002 to December 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987048
- Sponsor's protocol ID
- CSSM
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome
- ClinicalTrials.gov ID
- NCT03987048
- Acronym / sponsor ID
- CSSM
- Conditions
- Septic Shock, Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Jun 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.
Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients with septic shock | – | Other: Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.All consecutive adult cirrhotic patients admitted to the ICU with septic shock from 2002 to 2013. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis who require ICU admission for septic shock
Key inclusion criteria (3 listed)
- age 18 or older
- diagnosis of cirrhosis
- diagnosis of septic shock at ICU admission
Key exclusion criteria (1 listed)
- prior liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.Data were collected regarding medical background, medical condition and management, both at admission and during the ICU stay. These included demographics, clinical, biological and therapeutic data. Outcome at ICU discharge and at one year were also recorded. | Other | Cirrhotic patients with septic shock |
Primary outcome
Short-term outcome: analysis of independent predictors of ICU mortality rate.
Time frame: Between ICU admission (from January 2002 to December 2013) and ICU discharge
The predictors assessed independently are the clinical data, site of infection, biological data, liver scoring systems, organ failure, organ support and simplified acute physiology score (SAPS II), expressed in percentage of patients. The mortality rate is expressed in percentage of patients.
Long-term outcome: analysis of independent predictors of one-year mortality rate.
Time frame: At one year after ICU admission (from January 2002 to December 2013)
The predictors assessed independently are the independent predictors found to be related to the short-term mortality rate, expressed in percentage of patients. The mortality rate is expressed in percentage of patients.
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 14 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Cirrhosis, run by Hospices Civils de Lyon at 1 site 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Short-term outcome: analysis of independent predictors of ICU mortality rate. (time frame: Between ICU admission (from January 2002 to December 2013) and ICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2019.