Lung TransplantNCT06283680
The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients
An observational study of Lung Transplant, run by Aylin Seylam Küşümler at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Lung transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 213 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2023to 31 May 2024
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Lung Transplant
- Being tested
- Lung transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ex patients on the lung transplant waiting list Receives: Procedure: Lung transplantation | |
| Group 2 | Tansplant patients Receives: Procedure: Lung transplantation | |
| Group 3 | Patients waiting on the current list Receives: Procedure: Lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.
Measured: For one month period
Secondary outcomes (1)
Nutrition risk index
BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.
Measured: For one month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Feb 2023
- Primary completion28 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies 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
- Retrospective
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aylin Seylam Küşümler
- Sponsor type
- University, hospital or other
- Collaborators
- Koşuyolu Yüksek İhtisas Training and Research Hospital
- Responsible party
- Sponsor-investigator, Aylin Seylam Küşümler, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283680
- Sponsor's protocol ID
- 2024
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06283680
- Acronym / sponsor ID
- 2024
- Conditions
- Lung Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Aylin Seylam KüşümlerUniversity, hospital or other
- Collaborators
- Koşuyolu Yüksek İhtisas Training and Research Hospital
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Lung transplantationEx patients on the lung transplant waiting list |
| Group 2 | – | Procedure: Lung transplantationTansplant patients |
| Group 3 | – | Procedure: Lung transplantationPatients waiting on the current list |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung transplantationThree 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. | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
BMI
Time frame: For one month period
BMI values are evaluated for the patients for patients waiting on the transplant list, transplanted and exited.
1 secondary outcome
Nutrition risk index
Time frame: For one month period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
Related trials for Lung Transplant
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Transplant, run by Aylin Seylam Küşümler at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
BMI (time frame: For one month period). 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 8 Apr 2024.