ICU PatientsNCT02742571
Validation of PINI Score in ICU
An observational study of ICU Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients
- What is being tested?
- non applicable
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Jul 2016
- 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: ICU patients
Who may be able to join
- Both patient in ICU
Who cannot join
- minor patient
- No possibility to calculate PINI score
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Sébastien PERBET
About this study
Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU
Read the detailed description
Main objective: to evaluate the relationship between PINI score and biomarker related to PINI, and 28 days mortality in ICU
Secondary objectives:
- to evaluate the relationship between PINI score (and biomarkers related to PINI) and morbidity in ICU : SOFA score, duration of ventilation, duration of antibiotherapy, duration of extra renal epuration, length of stay
- to evaluate the relationship between PINI score (and biomarkers related to PINI) and nutrition in ICU (type of nutrition, calorie content)
- Conditions
- ICU Patients
- Being tested
- non applicable
- Keywords
- Biological evaluation of denutrition, Denutrition, PINI score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non applicableOther
What is being measured
The primary outcome is the main question the study is designed to answer.
PINI Score
Measured: at day 1
Biomarkers related to PINI
Measured: at day 1
Mortality at 28 days
Measured: after admission
Secondary outcomes (6)
Length of stay
Measured: at day 1
Duration of ventilation
Measured: at day 1
Duration of antibiotherapy
Measured: at day 1
Duration of renal replacement therapy
Measured: at day 1
Type of nutrition (enteral/parenteral)
Measured: at day 1
Calorie content per day
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742571
- Sponsor's protocol ID
- CHU-0258
- Status last verified
- Jun 2016
- First submitted
- 3 Mar 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of PINI Score in ICU
- ClinicalTrials.gov ID
- NCT02742571
- Acronym / sponsor ID
- CHU-0258
- Conditions
- ICU Patients
- Keywords
- Biological evaluation of denutrition, Denutrition, PINI score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 19 Apr 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.
Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU
Detailed description
Main objective: to evaluate the relationship between PINI score and biomarker related to PINI, and 28 days mortality in ICU
Secondary objectives:
- to evaluate the relationship between PINI score (and biomarkers related to PINI) and morbidity in ICU : SOFA score, duration of ventilation, duration of antibiotherapy, duration of extra renal epuration, length of stay
- to evaluate the relationship between PINI score (and biomarkers related to PINI) and nutrition in ICU (type of nutrition, calorie content)
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (1 listed)
- Both patient in ICU
Key exclusion criteria (3 listed)
- minor patient
- No possibility to calculate PINI score
- Pregnant woman
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 |
|---|---|---|
| non applicable | Other | – |
Primary outcome
PINI Score
Time frame: at day 1
Biomarkers related to PINI
Time frame: at day 1
Mortality at 28 days
Time frame: after admission
6 secondary outcomes
Length of stay
Time frame: at day 1
Duration of ventilation
Time frame: at day 1
Duration of antibiotherapy
Time frame: at day 1
Duration of renal replacement therapy
Time frame: at day 1
Type of nutrition (enteral/parenteral)
Time frame: at day 1
Calorie content per day
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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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.
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 ICU Patients, run by University Hospital, Clermont-Ferrand 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PINI Score (time frame: at day 1). The study lists 3 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 27 Jun 2016.