Clinical trial NCT03709498: Nutritional Status in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Nutritional Status as a Prognostic Marker of Risk and Outcome in Patients Admitted to Hospital With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Diet
Nutritional Status
Acute Exacerbation
Phase Angle
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Brief summary: A cross sectional observation study of body composition in COPD patients consecutively hospitalized with acute exacerbation.

Detailed description: Skeletal muscle dysfunction and changes in body composition are important extra-pulmonary manifestations of chronic obstructive pulmonary disease (COPD) that occur in all stages of disease and are associated with poor outcome. In patients with COPD, bioelectrical impedance analysis (BIA) has usually been used to estimate fat-free mass (FFM) and body composition through predictive equations. Very few studies had focused on raw BIA data. The aim of this study is first describe the measurement of phase angle in patients with with acute exacerbation and second to determine the validity of phase angle in this group by assessing its relationship with established markers of function, disease severity and prognosis.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of COPD based on history
* Hospitalization with acute COPD exacerbation

Exclusion Criteria:

* Patients with history of recent surgery (major) and trauma (major)
* Patients with concomitant disease that might alter nutritional status (heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure, uncontrolled cor pulmonale).
* Contraindication to BIA including an implanted pacemaker, defibrillator or joint prosthesis

Primary outcomes:
measure: Phase Angle
timeFrame: 1 month
Secondary outcomes:
measure: Change in Forced vital capacity (FVC)
timeFrame: 1 month
measure: Correlation between phase angle and serum CRP levels.
timeFrame: 1 month
measure: Forced expiratory flow volume in one second (FEV1).
timeFrame: 1 month
measure: Length of Hospital Stay (LOS)
timeFrame: 1 month
measure: Phase Angle
timeFrame: 2 months
measure: Body Composition
timeFrame: 1 month.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Nutrition and Dietetics, Evaggelismos Hospital
state: Kolonaki
Study officials:
affiliation: Pulmonary Medicine Dept, Evangelismos Hospital,
name: Sotirios Kakkavas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: S. Kakavas, D. Karayiannis, A. Papanikolaou, A. Baschali, M. Sarantidou, A. Karachaliou, A. Karli, Z. Mastora, M. Palavra, G. Boulbasakos. Bioelectrical Impedance Analysis Phase Angle as a Prognostic Marker for Outcome in Patients Admitted in Hospital with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Clinical Nutrition 36:S101, 2017