Patient Hospitalized in Intensive Care UnitIMPRIMNCT02881268
Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit
An observational study of Patient Hospitalized in Intensive Care Unit, run by Rennes University Hospital at 1 site in France.
Trial summary
Open-label, non-randomized, prospective, single center, observational, translational study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Hospitalized in Intensive Care Unit
- What is being tested?
- blood sample
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2016to 14 Jan 2021
- 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: Patient hospitalized in intensive care unit with or without sepsis
Who may be able to join
- Patient older than 18 years old
- Patient hospitalized in intensive care unit for any reason
- Patient with infection started less than 5 days before admission
- Patient with mechanical ventilation or not
- Patient with arterial catheter for an invasive monitoring of blood pressure
- Patient informed about the study protocol and approved to participate.
- Patients hospitalized for a severe bacterial infection (severe sepsis or septic shock)
- Patient hospitalized for a non-infectious disease
Who cannot join
- Pregnancy
- Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year
- Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (>0.5mg/kg/day)
Trial locations and contacts
1 site in 1 country.
About this study
Open-label, non-randomized, prospective, single center, observational, translational study
Read the detailed description
The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients.
Prevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Patient with sepsis | Patient hospitalized in intensive care unit Receives: Other: blood sample | |
| Patient without sepsis | Patient hospitalized in intensive care unit Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit
Measured: Day 14
Secondary outcomes (3)
Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression
Study of CMV reactivation and nosocomial infections
Measured: Day 14
Association of immunosuppression biomarkers with patients demographic data
Record of patient age and gender
Measured: Day 14
Association of immunosuppression biomarkers with patients clinical data
Record of severity score, duration of hospitalization, duration of mechanical ventilation, morbidity
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start19 Jan 2016
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Hospitalized in Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881268
- Sponsor's protocol ID
- 35RC15_9903_IMPRIM
- Acronym
- IMPRIM
- Status last verified
- Jan 2022
- First submitted
- 18 Aug 2016
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02881268
- Acronym / sponsor ID
- IMPRIM / 35RC15_9903_IMPRIM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Open-label, non-randomized, prospective, single center, observational, translational study
Detailed description
The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients.
Prevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with sepsis | – | Other: blood samplePatient hospitalized in intensive care unit |
| Patient without sepsis | – | Other: blood samplePatient hospitalized in intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in intensive care unit with or without sepsis
Key inclusion criteria (8 listed)
- Patient older than 18 years old
- Patient hospitalized in intensive care unit for any reason
- Patient with infection started less than 5 days before admission
- Patient with mechanical ventilation or not
- Patient with arterial catheter for an invasive monitoring of blood pressure
Key exclusion criteria (3 listed)
- Pregnancy
- Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year
- Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (>0.5mg/kg/day)
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 |
|---|---|---|
| blood sample | Other | Patient with sepsis, Patient without sepsis |
Primary outcome
Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit
Time frame: Day 14
3 secondary outcomes
Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression
Time frame: Day 14
Association of immunosuppression biomarkers with patients demographic data
Time frame: Day 14
Association of immunosuppression biomarkers with patients clinical data
Time frame: Day 14
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 19 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Patient Hospitalized in Intensive Care Unit
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
RecruitingObservational study
An Investigation of The Relationship Between Muscle Mass, Physiological Parameters, and Blood Gas Levels in Adult Patients Hospitalized in The Intensive Care Unit
Intensive Care (ICU)
Recruiting
Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility
Hospitalized Patients, ICU Hospitalization
Not yet recruiting
Digital Stimulation and Anxiety and Sleep Quality in Intensive Care Unit Patients
ICU Patients
Recruiting
Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA]
Intensive Care Unit Syndrome
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 Patient Hospitalized in Intensive Care Unit, run by Rennes University Hospital 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 8 inclusion and 3 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 19 Jan 2022. 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?
Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit (time frame: Day 14). 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 19 Jan 2022.