Immunosuppressants to Postoperative Infection and Death

Recruiting

• Conditions: Organ Transplantation; Immunosuppressive Agents; Cohort Study
• Interventions: Drug: Immunosuppressive Agents

• Registration Number: NCT06121804
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-20
• Status Verified: 2023-10
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-11-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with organ transplantation	Immunosuppressive Agents	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 without organ transplantation	Immunosuppressive Agents	The general patients were enrolled as the comparison. We used propensity score matching (PSM) to establish a matched cohort.

Primary Outcome Measures

Name	Time	Method
Postoperative infection	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
Death	From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.	Death

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan