NCT06283680

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

February 21, 2024

Last Update Submit

April 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • BMI

    BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.

    For one month period

Secondary Outcomes (1)

  • Nutrition risk index

    For one month period.

Study Arms (3)

Group 1

Ex patients on the lung transplant waiting list

Procedure: Lung transplantation

Group 2

Tansplant patients

Procedure: Lung transplantation

Group 3

Patients waiting on the current list

Procedure: Lung transplantation

Interventions

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.

Group 1Group 2Group 3

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the study consisted of patients who applied to the lung transplantation outpatient clinic at Koşuyolu High Specialised Training and Research Hospital between 2016 and 2022, were listed, were waiting on the list, died while on the list, and received lung transplantation, and met the inclusion criteria.

You may qualify if:

  • End-stage lung disease
  • To be on the Lung Transplant list.
  • Being between the ages of 19-65
  • Not having severe psychiatric illness
  • Being fed orally
  • Volunteering to participate in the study for Patients Waiting on the Transplant List

You may not qualify if:

  • To be removed from the Lung Transplant List
  • Being pregnant or lactating
  • Severe psychiatric illness
  • Peg or Jeg feeding (unable to feed orally)
  • Missing data in the file

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OkanU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lung Transplantation

Intervention Hierarchy (Ancestors)

Pulmonary Surgical ProceduresThoracic Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

February 28, 2023

Primary Completion

April 28, 2024

Study Completion

May 31, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations