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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06268171
Other study ID # 2023_0214
Secondary ID 2023-A02390-45
Status Not yet recruiting
Phase
First received
Last updated
Start date March 4, 2024
Est. completion date November 5, 2025

Study information

Verified date February 2024
Source Hopital Foch
Contact Elisabeth HULIER-AMMAR
Phone 00 33 1 46 25 11 75
Email e.hulier-ammar@hopital-foch.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality. After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU. Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity. In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date November 5, 2025
Est. primary completion date September 4, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient over the age of 18 - Patient registered on the lung transplant list at Hôpital Foch for a single or double-lung transplant - Patient who did not object to inclusion in the study - Patient affiliated to a French health insurance plan Exclusion Criteria: - Patient listed for a combined transplant (heart-lung, liver-lung, lung-kidney) - Patient on national priority list (super-emergency) - Pregnant or breast-feeding patient - Patient under guardianship

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ultrasound measurement of the cross-sectional area of the rectus femoris
ultrasound measurement of the cross-sectional area of the rectus femoris at D-1 and D+3, +7 , +14

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation Baseline and Day 7
Secondary Measure change in CSA-RF at D7 according to LT pattern Baseline and day 14
Secondary Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7 Baseline and day 7
Secondary Determine the relationship between CSA-RF at D-1 and Body Mass Index Baseline
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