Postoperative Infections and Immune Profiles in Patients Undergoing LVAD Implantation
NCT ID: NCT07255716
Last Updated: 2025-12-01
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
120 participants
OBSERVATIONAL
2020-06-01
2026-10-01
Brief Summary
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Detailed Description
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2. Study design:
Design Type: Retrospective, observational, multi-center study Study Population: patients who received LVAD implantations between June 2020 and October 2025 at 2 centers in China.
Primary Objective: To evaluate the incidence of infection rate after LVAD implantation .
Secondary Objectives: To identify factors associated with infection, assess the immune status alteration after LVAD implantation.
3. Study Population Inclusion criteria (i) age \>18 years, (ii) indication for LVAD implantation, (iii)informed consent.
Exclusive criteria included active preoperative infection and no other circulatory support devices were used preoperatively
4\. Data Collection
1. Demographic and clinical characteristics from medical records, including age, sex, comorbidities, heart failure etiologies, INTERMACS profiles.
2. Surgical details, including device type, duration of support, and concomitant surgeries.
3. Infection prevention measures, including the use of prophylactic antibiotics, skin decolonization procedures, driveline fixation sutures, etc.
4. Clinical examination data, including blood tests, imaging studies, cardiac function tests, etc.
5. Regular follow-up data, including clinical blood tests, changes in cardiac function, and incidence of infection events, along with collection of peripheral blood for assessment of immune status.
5\. Statistical Analysis Descriptive statistics will be used to summarize patient demographics, infection incidence, and outcomes. Subgroup analyses will be conducted based on the types of postoperative infections.
Longitudinal clinical examination data were analyzed using longitudinal linear mixed models, with appropriate post-hoc comparisons via the emmeans package, applying Bonferroni adjustment for multiple testing.
Statistical significance will be indicated by the specific p-values for each comparison.
6\. Expected Outcomes and Significance Primary Outcome: Incidence of different types of infections after LVAD implantation.
Secondary Outcomes: the longitudinal changes in immune indicators after LVAD implantation and the association between infection incidence and immune status.
The findings of this study may offer guidance for the clinical management of postoperative infections and support the development of potential intervention strategies.
7\. Timeline Study Period: June 2020 to October 2025 Data Analysis Period: November 2024 to January 2025
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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group1: All patients who met the inclusion criteria for LVAD implantation
none intervention
none intervention
Interventions
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none intervention
none intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Locations
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Fuwai Hospital
Beijing, Xicheng, China
Countries
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Other Identifiers
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2023CXGC011
Identifier Type: -
Identifier Source: org_study_id
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