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

Intensive Care Unit Patients Clinical Trial

— PAP  

Official title:

PHASE ANGLE PROJECT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907347
• Other study ID #: CEREH-13-022
• Status: Completed
• Phase: N/A
• First received: July 13, 2013
• Last updated: October 24, 2017
• Start date: March 1, 2013
• Est. completion date: August 31, 2014

Study information

• Verified date: October 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 31, 2014
• Est. primary completion date: August 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care Unit Patients

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels
Brazil	Universidade Federal de Pelotas	Pelotas
Croatia	Univ. Hospital Center Zagreb	Zagreb
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Rouen University Hospital	Rouen
Israel	Rabin Medical Center	Petah Tikva
Lithuania	Vilnius University Hospital	Vilnius
Poland	Stanley Dudrick's Memorial Hospital	Skawina
Spain	Clinica USP Palmaplanas	Palma de Mallorca
Switzerland	Geneva University Hospital	Geneva 14

Sponsors (10)

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

Countries where clinical trial is conducted

Belgium,  Brazil,  Croatia,  France,  Israel,  Lithuania,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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