Drug-drug InteractionNCT06682325
Pharmaco-proteomic Platform to Evaluate Drug Interactions in Liver Transplant Patients
An observational study of Drug-drug Interaction and Liver Transplantation, run by Pontificia Universidad Catolica de Chile at 3 sites in Chile.
Trial summary
The goal of this observational study is to enhance the ability to forecast kidney failure in liver transplant patients in the ICU under multidrug treatment by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-drug Interaction, Liver Transplantation
- What is being tested?
- Multi-drug interaction
- How many people
- 48 participants
- Where
- 3 sitesChile
- Study dates
- 1 Jun 2023to 5 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant patients admitted to intensive care after surgery
Who may be able to join
- Liver transplant patients undergoing surgery at UC Christus Hospital
Who cannot join
- Patients on renal replacement therapy
- Patients for whom no clinical or pharmacological registry is available
Trial locations and contacts
3 sites in 1 country.
Chile3 sites, 1 recruiting
- Recruiting
Hospital ClínicoUC-Christus
Santiago, Santiago Metropolitan, 8330024
Nelson Barrera, PhD, 56987687058, nbarrerr@uc.cl
Jaime Retamal, PhD
- Active, not recruiting
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan
- Active, not recruiting
Universidad de Valparaíso
Valparaíso, Valparaiso
About this study
Official title: Development of a Pharmaco-proteomic Platform to Evaluate Potential Drug Interactions and Their Clinical Impact in Liver Transplant Patients Undergoing Multidrug Treatment
The goal of this observational study is to enhance the ability to forecast kidney failure in liver transplant patients in the ICU under multidrug treatment by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. The main outcomes it aims to develop are:
- Design the multidrug web computing platform with available information on drug pair interactions (DDIs).
- Integrate the proteomic and clinical data of liver transplant patients into the IT platform.
- Implement the multidrug web platform to predict the clinical evolution of liver transplant patients.
Read the detailed description
The aim of this project is to enhance the ability to forecast kidney failure for liver transplant patients in the ICU by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. This integrated platform enables the prediction of the development of AKI in patients who have undergone OLT. Through the integration of mathematical models, the platform captures complex interactions between multiple drugs and proteomics data from patients, contributing to an improved predictive capacity for AKI outcomes.
By leveraging proteomic insights, personalized therapeutic interventions can be devised, promoting safer and more effective treatments. This research seeks to empower medical professionals with comprehensive information to navigate the complex landscape of drug interactions and personalized treatment strategies, ultimately contributing to improved patient outcomes and healthcare practices in the realm of liver transplantation.
- Conditions
- Drug-drug Interaction, Liver Transplantation
- Being tested
- Multi-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-drug interactionOther
The clinical impact associated with the use of multiple drugs in liver transplant patients during their stay in ICU will be evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a web platform that combines information on interactions between multiple drugs and proteomic and clinical profiles, to predict the clinical evolution in liver transplant patients hospitalized in the ICU
Periodic developmental assessments will be carried out (Analysis of drug interaction graphs, Design of the interaction web platform, Integration of omics and clinical data into the web platform)
Measured: 18 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jun 2023
- Primary completion5 Dec 2024 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Valparaiso, Universidad Adolfo Ibañez
- Responsible party
- Sponsor
- Investigators
- Nelson Barrera, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682325
- Sponsor's protocol ID
- 23I10401
- Status last verified
- Jul 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Pharmaco-proteomic Platform to Evaluate Potential Drug Interactions and Their Clinical Impact in Liver Transplant Patients Undergoing Multidrug Treatment
- ClinicalTrials.gov ID
- NCT06682325
- Acronym / sponsor ID
- 23I10401
- Conditions
- Drug-drug Interaction, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Universidad de Valparaiso, Universidad Adolfo Ibañez
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 12 Nov 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 goal of this observational study is to enhance the ability to forecast kidney failure in liver transplant patients in the ICU under multidrug treatment by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. The main outcomes it aims to develop are:
- Design the multidrug web computing platform with available information on drug pair interactions (DDIs).
- Integrate the proteomic and clinical data of liver transplant patients into the IT platform.
- Implement the multidrug web platform to predict the clinical evolution of liver transplant patients.
Detailed description
The aim of this project is to enhance the ability to forecast kidney failure for liver transplant patients in the ICU by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. This integrated platform enables the prediction of the development of AKI in patients who have undergone OLT. Through the integration of mathematical models, the platform captures complex interactions between multiple drugs and proteomics data from patients, contributing to an improved predictive capacity for AKI outcomes.
By leveraging proteomic insights, personalized therapeutic interventions can be devised, promoting safer and more effective treatments. This research seeks to empower medical professionals with comprehensive information to navigate the complex landscape of drug interactions and personalized treatment strategies, ultimately contributing to improved patient outcomes and healthcare practices in the realm of liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant patients admitted to intensive care after surgery
Key inclusion criteria (1 listed)
- Liver transplant patients undergoing surgery at UC Christus Hospital
Key exclusion criteria (2 listed)
- Patients on renal replacement therapy
- Patients for whom no clinical or pharmacological registry is available
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 |
|---|---|---|
| Multi-drug interactionThe clinical impact associated with the use of multiple drugs in liver transplant patients during their stay in ICU will be evaluated. | Other | – |
Primary outcome
Develop a web platform that combines information on interactions between multiple drugs and proteomic and clinical profiles, to predict the clinical evolution in liver transplant patients hospitalized in the ICU
Time frame: 18 to 24 months
Periodic developmental assessments will be carried out (Analysis of drug interaction graphs, Design of the interaction web platform, Integration of omics and clinical data into the web platform)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Nelson Barrera, PhD principal investigator
Pontificia Universidad Catolica de Chile
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-drug Interaction and Liver Transplantation, run by Pontificia Universidad Catolica de Chile at 3 sites in Chile.
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 1 inclusion and 2 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile. 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?
Contact Nelson Barrera, PhD (56987687058, nbarrerr@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a web platform that combines information on interactions between multiple drugs and proteomic and clinical profiles, to predict the clinical evolution in liver transplant patients hospitalized in the ICU (time frame: 18 to 24 months). 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 12 Nov 2024.