Prognosis Value of Bioimpedance Analysis (BIA) Phase Angle at Admission in Intensive Care Unit (ICU) Patients (PAP)

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).

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 Overview

• Status: Completed
• Conditions: Intensive Care Unit Patients

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme University Hospital
• Brazil
  • Pelotas, Brazil
    • Universidade Federal de Pelotas
• Croatia
  • Zagreb, Croatia, Zagreb
    • Univ. Hospital Center Zagreb
• France
  • Clermont-Ferrand, France, 63009
    • Clermont-Ferrand University Hospital
  • Rouen, France, 76031
    • ROUEN university hospital
• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital
• Poland
  • Skawina, Poland, 32-050
    • Stanley Dudrick's Memorial Hospital
• Spain
  • Palma de Mallorca, Spain, 07010
    • Clinica USP Palmaplanas
• Switzerland
  • Geneva 14, Switzerland, 1211
    • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in medical and surgical intensive care units.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICU patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on 28-day mortality	28-day after intensive care unit admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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	within the 48 first hours of ICU stay

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: University Hospital, Rouen; Rabin Medical Center; University Hospital, Clermont-Ferrand; Clinical Hospital Centre Zagreb; Federal University of Pelotas; Stanley Dudrick's Memorial Hospital; Erasme University Hospital; Vilnius University; Clinica USP Palmaplanas

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): August 15, 2014
• Study Completion (Actual): August 31, 2014

Study Registration Dates

• First Submitted: July 13, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: nutrition; body composition; mortality; intensive care unit (ICU); nosocomial infection; bioimpedance analysis; phase angle
• Other Study ID Numbers: CEREH-13-022