Exhaled Volatile Organic Compounds as Potential Predictive Biomarkers of Chronic Kidney and Liver Rejection After Transplants
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Volatile organic compounds after liver transplant
Study Overview
Brief Summary
Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease.
Chronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants.
While acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible.
Considering the recent application of the breathomic to liver and kidney disease and the difficulty in the early detection of chronic rejection after liver and kidney transplants, the analysis of the exhaled VOCs pattern could help early detection of chronic rejection allowing a prompt medical treatment.
Detailed Description
Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease.
Nowadays the short and long term success rate of kidney and liver trasplants is pretty hight. Nevertheless, transplant rejection remains one of the biggest limitations with a strong impact on patients survival.
Usually acute rejection occurs within 3 months after the transplant and is the most common cause of transplant failure and the most common indication for re-transplantation .
Chronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants.
While acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients eligible for liver or kidney transplant
- •Written informed consent
Exclusion Criteria
- •Acute liver failure
- •Acute liver and kidney rejection
- •Re-transplant
- •Pregnancy
- •Any psychiatric disease
Arms & Interventions
Liver/kidney transplant
The breath of patients undergoing liver or kidney transplant will be sampled and analysed
Intervention: Breath analysis (Other)
Outcomes
Primary Outcomes
Volatile organic compounds after liver transplant
Time Frame: 1 year
to evaluate the pattern of volatile organic compounds able to identify the onset of chronic failure/rejection after liver transplants
Volatile organic compounds in end stage liver disease
Time Frame: 30 days
to evaluate the pattern of volatile organic compounds in patients elegible for liver transplant
Volatile organic compounds in end stage kidney disease
Time Frame: 30 days
to evaluate the pattern of volatile organic compounds in patients elegible for kidney transplant
Secondary Outcomes
No secondary outcomes reported