Clinical trial NCT01907347: Prognosis Value of Bioimpedance Analysis (BIA) Phase Angle at Admission in Intensive Care Unit (ICU) Patients
Official title: PHASE ANGLE PROJECT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Patients
Keywords: intensive care unit (ICU)
body composition
phase angle
mortality
nosocomial infection
bioimpedance analysis
nutrition
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
name: Erasme University Hospital
name: Federal University of Pelotas
name: Clinical Hospital Centre Zagreb
name: University Hospital, Rouen
name: Rabin Medical Center
name: Vilnius University
name: Stanley Dudrick's Memorial Hospital
name: Clinica USP Palmaplanas
First posted: 2013-07-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in medical and surgical intensive care units.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mortality
timeFrame: 28-day after intensive care unit admission
Secondary outcomes:
measure: number of nosocomial infections
timeFrame: 28 day after the intensive care unit admission
measure: length of mechanical ventilation
timeFrame: day 1 to day 28 after ICU admission
measure: ICU length of stay
timeFrame: day 1 to ICU discharge or death
measure: hospital length of stay
timeFrame: day 1 to hospital discharge
measure: fat-free mass measurement by bioimpedance analysis and third lumbar vertebra-targeted computerized tomography
timeFrame: day 1 to day 28
measure: ICU severity scores, APACHE II and SAPS II
timeFrame: within the 48 first hours of ICU stay
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
city: Pelotas
country: Brazil
facility: Universidade Federal de Pelotas
city: Zagreb
country: Croatia
facility: Univ. Hospital Center Zagreb
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
city: Palma de Mallorca
country: Spain
facility: Clinica USP Palmaplanas
city: Geneva 14
country: Switzerland
facility: Geneva University Hospital
Study officials:
References:
citation: 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.