The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients

Lung Transplant Clinical Trial

Official title:

The Effect of Nutritional Status and Body Mass Index on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients on the Lung Transplant List

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06283680
• Other study ID #: 2024
• Status: Active, not recruiting
• Start date: February 28, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.

Description:

This study aimed to determine the nutritional status of patients awaiting lung transplantation and examine the effects of nutritional status, immunonutrition use, and BMI on lung capacity, mortality, and health status after lung transplantation. The study was designed in two different periods. The first period was a retrospective descriptive study. During this study, we will examine the retrospective nutritional status of patients who are waiting for lung transplantation, those who exited while on the list, or those who have received lung transplantation. In the second phase, we will conduct face-to-face interviews with patients on the lung transplant list, take bioelectrical impedance analyses (BIA), and record 24-hour food consumption to examine their detailed nutritional status.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: May 31, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. End-stage lung disease

2. To be on the Lung Transplant list.

3. Being between the ages of 19-65

4. Not having severe psychiatric illness

5. Being fed orally

6. Volunteering to participate in the study for Patients Waiting on the Transplant List

Exclusion Criteria:

1. To be removed from the Lung Transplant List

2. Being pregnant or lactating

3. Severe psychiatric illness

4. Peg or Jeg feeding (unable to feed orally)

5. Missing data in the file

Related Conditions & MeSH terms

• Lung Transplant

Intervention

Procedure:
• Lung transplantation
Three different groups will be investigated with respect to the effect of NRI, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.

Locations

Country	Name	City	State
Turkey	OkanU	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Aylin Seylam Küsümler	Kosuyolu Yüksek Ihtisas Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.	For one month period
Secondary	Nutrition risk index	BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.	For one month period.