MalnutritionNCT04639648
Nutritional Status Evaluation of Hospitalized Patients With Acute Respiratory Failure and COPD
An observational study of Malnutrition and COPD, run by Fondazione Fatebenefratelli at 1 site in Italy.
Trial summary
Malnutrition is a comorbidity oftenly seen in COPD patients who have progressive chronic inflammation and severity. The investigators aimed to determine the impact of nutritional status and nutrition-related factors on prolonged length of stay in hospitalized patients with acute respiratory failure and COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, COPD
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 2 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 hospitalized patients with acute respiratory failure and COPD.
Who may be able to join
- hospitalized patients with acute respiratory failure and COPD
Who cannot join
- chronic renal failure
- cancer
- cirrhosis
- inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fatebenefratelli San Giovanni Calibita-Isola Tiberina Hospital
Rome, Lazio, 00186
About this study
Malnutrition is a comorbidity oftenly seen in COPD patients who have progressive chronic inflammation and severity. The investigators aimed to determine the impact of nutritional status and nutrition-related factors on prolonged length of stay in hospitalized patients with acute respiratory failure and COPD. Nutritional status has been defined as an individual's health condition as it is influenced by the intake and utilization of nutrients (Todhunter, 1970). Nutritional status can be defined by energy balance, body composition and body function, moreover the chronic inflammation and the physical activity have an important role. In the study is used some tools (anthropometry, Nutritional Risk Screening [NRS 2002], food intake, body composition, Fat-Free Mass Index [FFMI], diaphragm ultrasound for evaluating diaphragmatic mobility, blood tests, hand) to define nutritional status. The investigatos'll analyze prevalance of malnutrition in the sample and the correlation of malnutrition with prolonged length of stay in hospitalized patients with acute respiratory failure and COPD.
Read the detailed description
Introduction:
Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. In Italy the disease frequency is growing, our last estimate by National Health Service in the year 2014 shows more than 6 cases on 100 people (6% of the population).
Materials and methods:
- Sample selection: 40 partecipants were enrolled in the Internal Medicine Department of S. Giovanni Calibita Fatebenefratelli Hospital in Rome
- Data collection: anamnesis (sex, age, GOLD classification, active pathologies, length of stay in hospital); Nutritional Risk Screening [NRS 2002]; food Intake: as pergentage of ingesta in the last meal; (MMRC) dyspnea scale.
- Anthropometry parameters: height , body weight, arm circumference, triceps skin fold thickness and Body Mass index was calculated [BMI = weight (Kg) / (stature (m))²]
- Body Composition: bioimpedance analysis (fat free mass, fat mass, phase angle, fat free mass index [height-normalized index of FFM, which is calculated by dividing FFM (in kg) by height (in m2) ]).
- Blood tests: albumin (g/dL), transferrin (mg/dL), prealbumin (mg/dL), lymphocytes /mm3, Retinol-binding protein (mg/dL), PCR (mg/L), NLR (neutrophil-lymphocyte ratio)
- Functional examinations: handgrip
- Diaphragm ultrasound performed during quiet respiration. The right diaphragm is analyzed through the liver window. The transducer is placed in the anterior subcostal region between the mid clavicular and anterior axillary lines. The ultrasound beam should reach the posterior part of the diaphragm. In the B mode view, the diaphragm is identified as an echogenic line between the interface of the lung and liver or spleen. Then, M mode is performed to record diaphragmatic excursion during respiration.
Statistics Demographic and clinical features were summarized with the descriptive statistic (mean, standard deviation, median, interquartile range) for continuous variables and with absolute frequencies and percentage for categorical variables. We used Chi-Square Tests or Fisher's Exact Test (if n < 5) for comparison of percentages. We used the Pearson or Sperman correlation to evaluate the relationship between the continuous variables.
Ethical approval and consent to participate All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and the national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
- Conditions
- Malnutrition, COPD
- Medical subject headings
- Malnutrition, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between BMI (Kg/m2) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
BMI is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Measured: Baseline
Correlation between dynapenia using handgrip strength test (Kg) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
The dynapenia is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Measured: Baseline
Correlation between fat free mass (Kg) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Body composition (fat free mass) is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Measured: Baseline
Correlation between food Intake: as pergentage of ingesta in the last meal and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Food intake is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Measured: Baseline
Correlation between albumin (g/dL) blood serum level on prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Albumin is very influenced by nutritional status and low blood level means that nutritional status is not good
Measured: Baseline
Correlation between arm circumference (cm) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Arm circumference is muscle mass related and is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Measured: Baseline
Correlation between tricipital skin fold thickness (mm) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Tricipital skin fold thickness is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Measured: Baseline
Secondary outcomes (6)
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and BMI (Kg/m2) in hospitalized patients with acute respiratory failure and COPD
BMI is a tool that define nutritional status, the aim is to determinate if diaphragm ultrasound is influenced by nutritional status
Measured: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and dynapenia using handgrip strength test (Kg) in hospitalized patients with acute respiratory failure and COPD
The dynapenia is a tool to define nutritional status, the aim is to determinate if diaphragm ultrasound is influenced by nutritional status
Measured: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and body composition - fat free mass (Kg) in hospitalized patients with acute respiratory failure and COPD
Body composition (fat free mass) is a tool to define nutritional status, the aim is to determinate if diaphragm ultrasound is influenced by nutritional status
Measured: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and food Intake: as pergentage of ingesta in the last meal in hospitalized patients with acute respiratory failure and COPD
Food intake is a tool to define nutritional status, the aim is to determinate if diaphragm ultrasound is influenced by nutritional status
Measured: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and arm circumference (cm) in hospitalized patients with acute respiratory failure and COPD
Arm circumference is muscle mass related and is a tool to define nutritional status, the aim is to determinate if diaphragm ultrasound is influenced by nutritional status
Measured: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and tricipital skin fold thickness (mm) in hospitalized patients with acute respiratory failure and COPD
Tricipital skin fold thickness is a tool to define nutritional status, the aim is to determinate if diaphragm ultrasound is influenced by nutritional status
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Aug 2019
- Primary completion2 May 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Di Lazzaro, Fondazione Fatebenefratelli
- Investigators
- Dario Manfellotto, MD, Study director, Fatebenefratelli San Giovanni Calibita Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639648
- Sponsor's protocol ID
- 1465/CE Lazio 1
- Status last verified
- Nov 2020
- First submitted
- 26 Sep 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Evaluation of Hospitalized Patients With Acute Respiratory Failure and COPD
- ClinicalTrials.gov ID
- NCT04639648
- Acronym / sponsor ID
- 1465/CE Lazio 1
- Conditions
- Malnutrition, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione FatebenefratelliUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition is a comorbidity oftenly seen in COPD patients who have progressive chronic inflammation and severity. The investigators aimed to determine the impact of nutritional status and nutrition-related factors on prolonged length of stay in hospitalized patients with acute respiratory failure and COPD. Nutritional status has been defined as an individual's health condition as it is influenced by the intake and utilization of nutrients (Todhunter, 1970). Nutritional status can be defined by energy balance, body composition and body function, moreover the chronic inflammation and the physical activity have an important role. In the study is used some tools (anthropometry, Nutritional Risk Screening [NRS 2002], food intake, body composition, Fat-Free Mass Index [FFMI], diaphragm ultrasound for evaluating diaphragmatic mobility, blood tests, hand) to define nutritional status. The investigatos'll analyze prevalance of malnutrition in the sample and the correlation of malnutrition with prolonged length of stay in hospitalized patients with acute respiratory failure and COPD.
Detailed description
Introduction:
Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. In Italy the disease frequency is growing, our last estimate by National Health Service in the year 2014 shows more than 6 cases on 100 people (6% of the population).
Materials and methods:
- Sample selection: 40 partecipants were enrolled in the Internal Medicine Department of S. Giovanni Calibita Fatebenefratelli Hospital in Rome
- Data collection: anamnesis (sex, age, GOLD classification, active pathologies, length of stay in hospital); Nutritional Risk Screening [NRS 2002]; food Intake: as pergentage of ingesta in the last meal; (MMRC) dyspnea scale.
- Anthropometry parameters: height , body weight, arm circumference, triceps skin fold thickness and Body Mass index was calculated [BMI = weight (Kg) / (stature (m))²]
- Body Composition: bioimpedance analysis (fat free mass, fat mass, phase angle, fat free mass index [height-normalized index of FFM, which is calculated by dividing FFM (in kg) by height (in m2) ]).
- Blood tests: albumin (g/dL), transferrin (mg/dL), prealbumin (mg/dL), lymphocytes /mm3, Retinol-binding protein (mg/dL), PCR (mg/L), NLR (neutrophil-lymphocyte ratio)
- Functional examinations: handgrip
- Diaphragm ultrasound performed during quiet respiration. The right diaphragm is analyzed through the liver window. The transducer is placed in the anterior subcostal region between the mid clavicular and anterior axillary lines. The ultrasound beam should reach the posterior part of the diaphragm. In the B mode view, the diaphragm is identified as an echogenic line between the interface of the lung and liver or spleen. Then, M mode is performed to record diaphragmatic excursion during respiration.
Statistics Demographic and clinical features were summarized with the descriptive statistic (mean, standard deviation, median, interquartile range) for continuous variables and with absolute frequencies and percentage for categorical variables. We used Chi-Square Tests or Fisher's Exact Test (if n < 5) for comparison of percentages. We used the Pearson or Sperman correlation to evaluate the relationship between the continuous variables.
Ethical approval and consent to participate All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and the national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 hospitalized patients with acute respiratory failure and COPD.
Key inclusion criteria (1 listed)
- hospitalized patients with acute respiratory failure and COPD
Key exclusion criteria (4 listed)
- chronic renal failure
- cancer
- cirrhosis
- inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between BMI (Kg/m2) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
BMI is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Correlation between dynapenia using handgrip strength test (Kg) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
The dynapenia is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Correlation between fat free mass (Kg) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Body composition (fat free mass) is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Correlation between food Intake: as pergentage of ingesta in the last meal and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Food intake is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Correlation between albumin (g/dL) blood serum level on prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Albumin is very influenced by nutritional status and low blood level means that nutritional status is not good
Correlation between arm circumference (cm) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Arm circumference is muscle mass related and is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
Correlation between tricipital skin fold thickness (mm) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Tricipital skin fold thickness is a tool to define nutritional status and its correlation with prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD is useful to understand the role of nutritional status in these patients
6 secondary outcomes
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and BMI (Kg/m2) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and dynapenia using handgrip strength test (Kg) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and body composition - fat free mass (Kg) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and food Intake: as pergentage of ingesta in the last meal in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and arm circumference (cm) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Correlation between diaphragm ultrasound performed during quiet respiration (mm) and tricipital skin fold thickness (mm) in hospitalized patients with acute respiratory failure and COPD
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Manfellotto, MD study director
Fatebenefratelli San Giovanni Calibita Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and COPD, run by Fondazione Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between BMI (Kg/m2) and prolonged length of stay (days) in hospitalized patients with acute respiratory failure and COPD (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.