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NCT Number: NCT01907347

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme University Hospital, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 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 outcomes

  1. number of nosocomial infections

    Time frame: 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.

  2. length of mechanical ventilation

    Time frame: 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.

  3. ICU length of stay

    Time frame: 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.

  4. hospital length of stay

    Time frame: 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.

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

    Time frame: 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.

  6. ICU severity scores, APACHE II and SAPS II

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • 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

Registry information

Official study title

PHASE ANGLE PROJECT

Acronym: PAP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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