Nutritional Status in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709498
• Other study ID #: 53/27-01-2016
• Status: Completed
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: September 2023
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Greece	Department of Nutrition and Dietetics, Evaggelismos Hospital	Athens	Kolonaki

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase Angle	The evaluation of phase angle will be performed by means of the electric bioimpedance apparatus. The measurements will be obtained with the patient in dorsal decubitus, barefoot, with the lower limbs slightly apart and without metal objects attached to the body, with electrodes placed on the right hand and foot.	1 month
Secondary	Change in Forced vital capacity (FVC)	Secondary endpoint will be the correlation between FVC and muscle mass.	1 month
Secondary	Correlation between phase angle and serum CRP levels.	Detect the serum CRP levels and then analyze the correlation between CRP and phase angle measurement.	1 month
Secondary	Forced expiratory flow volume in one second (FEV1).	Forced expiratory flow volume in one second following standards recommended by European Respiratory Society and correlation with muscle mass.	1 month
Secondary	Length of Hospital Stay (LOS)	Duration of Hospital Stay	1 month
Secondary	Phase Angle	The evaluation of the phase angle will be performed by means of the electric bioimpedance apparatus. The measurements will be obtained with the patient in dorsal decubitus, barefoot, with the lower limbs slightly apart and without metal objects attached to the body, with electrodes placed on the right hand and foot.	2 months
Secondary	Body Composition	Body composition will be assessed using bioelectrical impedance analysis (In Body 720, Biospace) at a standardized time after breakfast. Bioelectrical impedance analysis (BIA) is a simple, safe, non-invasive method to measure assess lean (e.g., muscle) vs. fat body compartments. Fat-free mass will be calculated by using disease-specific equations as described by Schols. Fat mass will then be calculated as total body weight minus fat-free mass. Such BIA measurements are accurate, comparable to other techniques used to assess body composition, and have been validated in patients with acute excerbation of COPD	1 month.