NCT01907347: PAP

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

Completed Last updated 26 October 2017

What this trial tests

trial in Intensive Care Unit Patients in 1,000 participants. Completed in 31 August 2014.

Timeline

1 March 2013

Primary endpoint
15 August 2014

31 August 2014

Quick facts

Lead sponsor	University Hospital, Geneva
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 March 2013
Primary completion	15 August 2014
Estimated completion	31 August 2014
Sites	10 locations across France, Belgium, Israel, Poland, Lithuania, Switzerland, Spain, Croatia

Conditions studied

• Intensive Care Unit Patients — all drugs for Intensive Care Unit Patients →

Sponsor

University Hospital, Geneva

Who can join

18 and older, any sex, with Intensive Care Unit Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fat-free mass at admission predicts 28-day mortality in intensive care unit patients: the international prospective observational study Phase Angle Project.
   Thibault R, Makhlouf AM, Mulliez A, Cristina Gonzalez M, et al · · 2016 · cited 92× · PMID 27515162 · DOI 10.1007/s00134-016-4468-3