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

NCT03709498 | Completed DMC

• 1 other identifier: 53/27-01-2016
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Diet; Nutritional Status; Acute Exacerbation; Phase Angle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Forced vital capacity (FVC)

  1 month

• Correlation between phase angle and serum CRP levels.

  1 month

• Forced expiratory flow volume in one second (FEV1).

  1 month

• Length of Hospital Stay (LOS)

  1 month

• Phase Angle

  2 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Department of Nutrition and Dietetics, Evaggelismos Hospital

Athens, Kolonaki, 10676, Greece

Location

Related 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

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sotirios Kakkavas, MD, PhD

  Pulmonary Medicine Dept, Evangelismos Hospital,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian, Department of Clinical Nutrition and Metabolism

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 17, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

GR (1)