NCT06682325

Brief 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. The main outcomes it aims to develop are:

  1. 1.Design the multidrug web computing platform with available information on drug pair interactions (DDIs).
  2. 2.Integrate the proteomic and clinical data of liver transplant patients into the IT platform.
  3. 3.Implement the multidrug web platform to predict the clinical evolution of liver transplant patients.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

November 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

November 7, 2024

Last Update Submit

November 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    18 to 24 months

Interventions

The clinical impact associated with the use of multiple drugs in liver transplant patients during their stay in ICU will be evaluated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Liver transplant patients admitted to intensive care after surgery

You may qualify if:

  • Liver transplant patients undergoing surgery at UC Christus Hospital

You may not qualify if:

  • Patients on renal replacement therapy
  • Patients for whom no clinical or pharmacological registry is available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universidad de Valparaíso

Valparaíso, Región de Valparaíso, Chile

ACTIVE NOT RECRUITING

Hospital ClínicoUC-Christus

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and serum samples from patients.

Study Officials

  • Nelson Barrera, PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelson Barrera, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 12, 2024

Study Start

June 1, 2023

Primary Completion

December 5, 2024

Study Completion

May 5, 2025

Last Updated

November 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations