Immunosuppressants to Postoperative Infection and Death

NCT06121804 | Unknown DMC

• 1 other identifier: CS2-21134
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplantation; Immunosuppressive Agents; Cohort Study

Outcome Measures

Primary Outcomes (2)

• Postoperative infection

  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

  Death

  From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.

Study Arms (2)

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

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

Interventions

Immunosuppressive Agents DRUG

Prescribing immunosuppressive agents

Patients with organ transplantation; Patients without organ transplantation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who underwent solid organ transplant (SOT)

You may not qualify if:

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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

RECRUITING

Related Links

• The Health and Welfare Data Science Center, Ministry of Health and Welfare Taiwan

MeSH Terms

Interventions

Immunosuppressive Agents

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Chien-Ying Lee, PhD

  Chung Shan Medical University

  STUDY CHAIR

Central Study Contacts

Chien-Ying Lee, PhD

CONTACT

886-4-24730022; cshd015@csmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: December 20, 2021
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)