Optimization of Nutritional State on the Outcome of Patients with Acute Exacerbation of Bronchiectasis

November 25, 2024 updated by: Hend Mohamed Sayed Mohamed, Assiut University

Impact of Optimization of Nutritional State on the Outcome of Patients with Acute Exacerbation of Bronchiectasis

Bronchiectasis is a chronic respiratory condition characterized by the abnormal and permanent dilation of the bronchi, leading to recurrent respiratory infections, chronic cough, and significant morbidity. The disease has gained increasing recognition due to its rising prevalence and the substantial burden it places on healthcare systems .

Recent studies have highlighted the importance of nutritional status in managing chronic respiratory diseases, including bronchiectasis. Malnutrition is prevalent among patients with bronchiectasis, particularly those experiencing frequent exacerbations. It has been shown that underweight patients have lower lung function and may face worse clinical outcomes compared to those with normal weight . Specifically, a study found that underweight individuals had a significantly lower forced expiratory volume in one second (FEV1) compared to their normal-weight counterparts, indicating a direct correlation between nutritional status and respiratory function .

Study Overview

Status

Not yet recruiting

Detailed Description

To evaluate the effects of nutritional optimization on clinical outcomes in patients experiencing an acute exacerbation of bronchiectasis. Specifically, the study seeks to:

  • Assess the Relationship Between Nutritional Status and Clinical Outcomes*: To investigate how improvements in nutritional status, measured through dietary intake, body weight, and biochemical markers, correlate with clinical outcomes such as length of hospital stay, frequency of exacerbations, and overall recovery.

    • *Evaluate the Effectiveness of Nutritional Interventions*: To determine the impact of specific nutritional interventions (e.g., high-protein diets, caloric supplementation, and micronutrient support) on the health status and recovery of patients during acute exacerbations.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Recruitment Patients will be recruited from inpatient wards. Informed consent will be obtained from all participants prior to enrollment.

Nutritional Assessment

  • **Baseline Assessment**:
  • Nutritional status will be determined using the Subjective Global Assessment (SGA) and biochemical markers (e.g., serum albumin).
  • Dietary intake will be assessed using a 3-day food diary or 24-hour dietary recall method.
  • **Nutritional Optimization**: Patients identified as malnourished will receive a tailored nutritional intervention, which may include:
  • High-protein dietary recommendations.
  • Caloric supplementation through protein shakes or high-calorie snacks.
  • Micronutrient supplementation as need

Data Collection

Data will be collected at three time points:

  1. **Baseline**: Upon admission.
  2. **During Hospitalization**: After the implementation of nutritional interventions.
  3. **Follow-Up**: Six months post-discharge, assessing long-term outcomes.

Description

Inclusion Criteria:

  • *Age*: Adults aged 18 years and older.

    • Diagnosis*: Confirmed diagnosis of bronchiectasis, as established by clinical evaluation and imaging studies (e.g., chest CT scan).
    • Acute Exacerbation*: Patients presenting with acute exacerbation symptoms, such as increased sputum production, worsening dyspnea, or chest pain.
    • Nutritional Assessment*: Patients identified as malnourished or at risk of malnutrition based on the Subjective Global Assessment (SGA) or similar nutritional screening tools.

Exclusion Criteria:

  • *Cognitive Impairment*: Patients with cognitive impairments that affect their ability to participate in the study or adhere to nutritional recommendations.

    • Current Enteral Feeding*: Patients receiving enteral nutrition or those with a feeding tube.

Recent Nutritional Interventions*: Patients who have recently undergone significant nutritional interventions (e.g., dietary changes, supplementation) within the past three months prior to enrollment.

*Pregnancy or Lactation*: Pregnant or lactating women, due to the need for specific nutritional considerations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asses The Change In Quality of life
Time Frame: base line
measured by the St. George's Respiratory Questionnaire (SGRQ).
base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2024

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

March 20, 2025

Study Registration Dates

First Submitted

October 27, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Bronchiectas nutritional state

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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