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

Completed

• Conditions: Intensive Care Unit Patients

• Registration Number: NCT01907347
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-01
• Study First Submitted: 2013-07-13
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-24
• Primary Completion: 2014-08-15
• Study Completion: 2014-08-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	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

Secondary Outcome Measures

Name	Time	Method
length of mechanical ventilation	day 1 to day 28 after ICU admission	To determine the impact of phase angle, and phase angle changes during ICU stay, at ICU admission on length of mechanical ventilation.
ICU length of stay	day 1 to ICU discharge or death	To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on ICU length of stay.
ICU severity scores, APACHE II and SAPS II	within the 48 first hours of ICU stay	Determine the relation between phase angle mortality predicted by the ICU severity scores, APACHE II and SAPS II
number of nosocomial infections	28 day after the intensive care unit admission	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.
hospital length of stay	day 1 to hospital discharge	To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on hospital length of stay.
fat-free mass measurement by bioimpedance analysis and third lumbar vertebra-targeted computerized tomography	day 1 to day 28	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.

Trial Locations

Locations (10)

Erasme University Hospital; 🇧🇪 Brussels, Belgium

Vilnius University Hospital; 🇱🇹 Vilnius, Lithuania

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland

Clinica USP Palmaplanas; 🇪🇸 Palma de Mallorca, Spain

Universidade Federal de Pelotas; 🇧🇷 Pelotas, Brazil

Univ. Hospital Center Zagreb; 🇭🇷 Zagreb, Croatia

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Rouen University Hospital; 🇫🇷 Rouen, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Geneva University Hospital; 🇨🇭 Geneva 14, Switzerland