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

NCT01907347 | Completed

• 1 other identifier: CEREH-13-022
• Study Type: observational
• Target: 1,000
• Locations: 9 countries
• Sites: 10

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.

Conditions

Intensive Care Unit Patients

Keywords

intensive care unit (ICU); body composition; phase angle; mortality; nosocomial infection; bioimpedance analysis; nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• number of nosocomial infections

  28 day after the intensive care unit admission

• length of mechanical ventilation

  day 1 to day 28 after ICU admission

• ICU length of stay

  day 1 to ICU discharge or death

• hospital length of stay

  day 1 to hospital discharge

• fat-free mass measurement by bioimpedance analysis and third lumbar vertebra-targeted computerized tomography

  day 1 to day 28

Study Arms (1)

ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in medical and surgical intensive care units.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Universidade Federal de Pelotas

Pelotas, Brazil

Location

Univ. Hospital Center Zagreb

Zagreb, Zagreb, Croatia

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63009, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Vilnius University Hospital

Vilnius, 08661, Lithuania

Location

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

Clinica USP Palmaplanas

Palma de Mallorca, 07010, Spain

Location

Geneva University Hospital

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27515162 DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, Head, Clinical Nutrition

Study Record Dates

• First Submitted: July 13, 2013
• First Posted: July 24, 2013
• Study Start: March 1, 2013
• Primary Completion: August 15, 2014
• Study Completion: August 31, 2014
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

PL (1); CH (1); IL (1); ES (1); LI (1); CR (1); BR (1); BE (1); FR (2)