Intensive Care Unit PatientsPAPNCT01907347
Prognosis Value of Bioimpedance Analysis (BIA) Phase Angle at Admission in Intensive Care Unit (ICU) Patients
An observational study of Intensive Care Unit Patients, run by University Hospital, Geneva at 10 sites in 9 countries.
Trial summary
Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Patients
- How many people
- 1,000 participants
- Where
- 10 sitesin 9 countries
- Study dates
- 1 Mar 2013to 31 Aug 2014
- 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 hospitalized in medical and surgical intensive care units.
Who may be able to join
- equal or more than 18 years
- expected ICU length of stay of more than 48 hours
- no readmission within the 48 hours following ICU discharge
- no Implanted Cardiac Devices
- no pregnancy or lactation
- affiliated to health insurance regimen
- informed consent by patient or next of kin.
Who cannot join
- age below 18 years
- expected ICU length of stay <48 hours
- readmission within the 48 hours following ICU discharge
- Implanted Cardiac Devices
- pregnancy or lactation
- non affiliated to health insurance regimen
- no informed consent by patient or next of kin.
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
France2 sites
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63009
Rouen University Hospital
Rouen, 76031
About this study
Official title: PHASE ANGLE PROJECT
Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However, solid data to support this association in ICU patients are lacking. Only one retrospective study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass with mortality. In a pilot study performed in 55 ICU patients, the investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation between PhA and mortality remains to be determined in ICU patients.
Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of ICU patients. Most of these scores are time consuming and suffer some degree of discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery patients).
Read more
PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU.
Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation by CT presents great practical significance due to its routine ICU use in the initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been evaluated in ICU patients.
Therefore, the investigators aim to conduct an international multicentre prospective observational study in ICU patients to assess the prognosis value of BIA PhA at admission, and to compare the performances of BIA and L3-targeted CT for FFM measurement.
- Conditions
- Intensive Care Unit Patients
- Keywords
- intensive care unit (ICU), body composition, phase angle, mortality, nosocomial infection, bioimpedance analysis, nutrition
- Medical subject headings
- Cross Infection
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 patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on 28-day mortality
Measured: 28-day after intensive care unit admission
Secondary outcomes (6)
number of nosocomial infections
To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on the number of nosocomial infections 28 day after the intensive care unit admission.
Measured: 28 day after the intensive care unit admission
length of mechanical ventilation
To determine the impact of phase angle, and phase angle changes during ICU stay, at ICU admission on length of mechanical ventilation.
Measured: day 1 to day 28 after ICU admission
ICU length of stay
To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on ICU length of stay.
Measured: day 1 to ICU discharge or death
hospital length of stay
To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on hospital length of stay.
Measured: day 1 to hospital discharge
fat-free mass measurement by bioimpedance analysis and third lumbar vertebra-targeted computerized tomography
To compare bioimpedance analysis and third lumbar vertebra-targeted computerized tomography (CT) performances for fat-free mass measurement in the subgroup of patients being performed a routine abdominal CT.
Measured: day 1 to day 28
ICU severity scores, APACHE II and SAPS II
Determine the relation between phase angle mortality predicted by the ICU severity scores, APACHE II and SAPS II
Measured: within the 48 first hours of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study start1 Mar 2013
- Primary completion15 Aug 2014
- Study completion31 Aug 2014
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 Intensive Care Unit PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand, Erasme University Hospital, Federal University of Pelotas, Clinical Hospital Centre Zagreb, University Hospital, Rouen, Rabin Medical Center, Vilnius University, Stanley Dudrick's Memorial Hospital, Clinica USP Palmaplanas
- Responsible party
- Principal investigator, Prof. Claude Pichard, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907347
- Sponsor's protocol ID
- CEREH-13-022
- Acronym
- PAP
- Status last verified
- Oct 2017
- First submitted
- 13 Jul 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thibault R, Makhlouf AM, Mulliez A, Cristina Gonzalez M, Kekstas G, Kozjek NR, Preiser JC, Rozalen IC, Dadet S, Krznaric Z, Kupczyk K, Tamion F, Cano N, Pichard C; Phase Angle Project Investigators. Fat-free mass at admission predicts 28-day mortality in intensive care unit patients: the international prospective observational study Phase Angle Project. Intensive Care Med. 2016 Sep;42(9):1445-53. doi: 10.1007/s00134-016-4468-3. Epub 2016 Aug 11.
PubMed 27515162
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE ANGLE PROJECT
- ClinicalTrials.gov ID
- NCT01907347
- Acronym / sponsor ID
- PAP / CEREH-13-022
- Conditions
- Intensive Care Unit Patients
- Keywords
- intensive care unit (ICU), body composition, phase angle, mortality, nosocomial infection, bioimpedance analysis, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand, Erasme University Hospital, Federal University of Pelotas, Clinical Hospital Centre Zagreb, University Hospital, Rouen, Rabin Medical Center, Vilnius University, Stanley Dudrick's Memorial Hospital, Clinica USP Palmaplanas
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 15 Aug 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 24 Jul 2013 (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.
Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However, solid data to support this association in ICU patients are lacking. Only one retrospective study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass with mortality. In a pilot study performed in 55 ICU patients, the investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation between PhA and mortality remains to be determined in ICU patients.
Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of ICU patients. Most of these scores are time consuming and suffer some degree of discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery patients).
PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU.
Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation by CT presents great practical significance due to its routine ICU use in the initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been evaluated in ICU patients.
Therefore, the investigators aim to conduct an international multicentre prospective observational study in ICU patients to assess the prognosis value of BIA PhA at admission, and to compare the performances of BIA and L3-targeted CT for FFM measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in medical and surgical intensive care units.
Key inclusion criteria (7 listed)
- equal or more than 18 years
- expected ICU length of stay of more than 48 hours
- no readmission within the 48 hours following ICU discharge
- no Implanted Cardiac Devices
- no pregnancy or lactation
Key exclusion criteria (7 listed)
- age below 18 years
- expected ICU length of stay <48 hours
- readmission within the 48 hours following ICU discharge
- Implanted Cardiac Devices
- pregnancy or lactation
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: 28-day after intensive care unit admission
To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on 28-day mortality
6 secondary outcomes
number of nosocomial infections
Time frame: 28 day after the intensive care unit admission
length of mechanical ventilation
Time frame: day 1 to day 28 after ICU admission
ICU length of stay
Time frame: day 1 to ICU discharge or death
hospital length of stay
Time frame: day 1 to hospital discharge
fat-free mass measurement by bioimpedance analysis and third lumbar vertebra-targeted computerized tomography
Time frame: day 1 to day 28
ICU severity scores, APACHE II and SAPS II
Time frame: within the 48 first hours of ICU stay
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 26 Oct 2017.
- Derived from this study: PubMed 27515162Thibault R, Makhlouf AM, Mulliez A, Cristina Gonzalez M, Kekstas G, Kozjek NR, Preiser JC, Rozalen IC, Dadet S, Krznaric Z, Kupczyk K, Tamion F, Cano N, Pichard C; Phase Angle Project Investigators. Fat-free mass at admission predicts 28-day mortality in intensive care unit patients: the international prospective observational study Phase Angle Project. Intensive Care Med. 2016 Sep;42(9):1445-53. doi: 10.1007/s00134-016-4468-3. Epub 2016 Aug 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Patients, run by University Hospital, Geneva at 10 sites in 9 countries.
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 7 inclusion and 7 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium, Brazil, Croatia, Israel and 4 more countries. 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: 28-day after intensive care unit admission). 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 NCT01907347, 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 26 Oct 2017.