Immunosuppressants to Postoperative Infection and Death

November 6, 2023 updated by: Chung Shan Medical University

The Cost-effectiveness Analysis of Immunosuppressants to Postoperative Infection and Death in the Patients With Organ Transplantation

The goal of this observational study is to explore the different immunosuppressive agents and related outcomes in organ transplantation patients in Taiwan. The main question it aims to answer is the risk of different immunosuppressive agents for infection and survival after transplant.

The study enrolled patients who underwent solid organ transplant (SOT), kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. We employed propensity score matching (PSM) to establish a matched cohort. The study will compare SOT patients and general patients to explore the risk of different immunosuppressive agents for infection and survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study used secondary data from the Longitudinal Health Insurance Database (LHID), a subset of the NHIRD provided by the Health and Welfare Data Science Center (HWDC) of the Ministry of Health and Welfare in Taiwan.

The HWDC encrypts personally identifying data to protect the privacy of beneficiaries. The database includes detailed clinical records from both the inpatient and outpatient claims of the beneficiaries of Taiwan's National Health Insurance program. This program has provided coverage for up to 99% of the country's population since 1995. The NHIRD can serve as a foundation for the procurement of real-world evidence to support clinical decisions and health-care policy-making.

Diagnostic data within the NHIRD from before 2016 and from 2016 or later are respectively coded using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.

The database was provided by the HWDC under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/cp-5119-59201-113.html).

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The present study enrolled patients who underwent SOTs between 2002 and 2013, specifically, kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. Patients were excluded from our study if they received more than one SOT, had an infectious disease diagnosis before their SOT, or had incomplete medical information in the NHIRD.

Description

Inclusion Criteria:

  • Patients who underwent solid organ transplant (SOT)

Exclusion Criteria:

  • Patients who received more than one SOT, had an infectious disease diagnosis before their SOT or had incomplete medical information in the database.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with organ transplantation
Patients who underwent SOTs between 2002 and 2013, specifically, kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants.
Drug: Immunosuppressive Agents
Prescribing immunosuppressive agents
Patients without organ transplantation
The general patients were enrolled as the comparison. We used propensity score matching (PSM) to establish a matched cohort.
Drug: Immunosuppressive Agents
Prescribing immunosuppressive agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative infection
Time Frame: From the date of underwent SOTs until the date of incident infection or date of death from any cause, whichever came first, assessed up to 5 years.
Postoperative infection contains Pneumocystis jiroveci pneumonia, cytomegalovirus disease, and Herpes simplex virus
From the date of underwent SOTs until the date of incident infection or date of death from any cause, whichever came first, assessed up to 5 years.
Death
Time Frame: From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.
Death
From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Study Chair: Chien-Ying Lee, PhD, Chung Shan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Estimated)

November 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS2-21134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The database used to support the findings of this study was provided by the Health and Welfare Data Science Center, Ministry of Health and Welfare (HWDC, MOHW) Taiwan under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/np-2497-113.html).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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