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A Comparison of Three Nutritional Assessment Methods Predicting Prognosis in COPD With Respiratory Failure

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ClinicalTrials.gov Identifier: NCT02942784
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Lu Xing, West China Hospital

Brief Summary:
This is a retrospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during January 2014 to March 2016 by review of medical records. The following variables will be retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2, nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic outcomes, and so on. The purpose of this study is to compare the predictive power of three widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic outcomes in a cohort of COPD patients with respiratory failure.

Condition or disease
Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prediction of Prognosis in Patients With Chronic Obstructive Pulmonary Disease With Respiratory Failure: A Comparison of Three Nutritional Assessment Methods
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of in-hospital death [ Time Frame: up to 27 months ]
  2. Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of 1-year death after discharge [ Time Frame: up to 27 months ]
  3. Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of 30-day readmission after discharge [ Time Frame: up to 27 months ]

Secondary Outcome Measures :
  1. Collection of Demographics (age, sex, marriage) [ Time Frame: up to 27 months ]
  2. Number of participants with in-hospital death [ Time Frame: up to 27 months ]
  3. Number of participants with 1-year death after discharge [ Time Frame: up to 27 months ]
  4. Number of participants with 30-day readmission after discharge [ Time Frame: up to 27 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with chronic obstructive pulmonary disease with respiratory failure during January 2014 to March 2016 at West China Hospital by review of medical records.
Criteria

Inclusion Criteria:

  • Newly diagnosis of COPD at West China Hospital during January 2014 to March 2016
  • Partial pressure of O2 (PaO2) < 60 mmHg and/or partial pressure of CO2 (PaCO2) >50 mmHg
  • Age ≥ 18 years
  • Respiratory rates > 23 bpm

Exclusion Criteria:

  • Pregnancy or during lactation
  • Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
  • Incomplete medical profiles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942784


Contacts
Contact: Lu Xing, MNS +86 18782942153 xinglu_0707@163.com

Locations
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Lu Xing, MNS    +86 18782942153    xinglu_0707@163.com   
Contact: Xiaolian Jiang, PhD    +86 18980995826    jiang_xiaolian0508@126.com   
Sponsors and Collaborators
West China Hospital

Responsible Party: Lu Xing, Principal Investigator, Master Degree, West China Hospital
ClinicalTrials.gov Identifier: NCT02942784     History of Changes
Other Study ID Numbers: COPD-001
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases