Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in MHD Patients

Completed

• Conditions: Arteriovenous Fistula Dysfunction; Cardio-cerebral Vascular Events
• Interventions: Other: depression

• Registration Number: NCT06070805
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

Depression is a common psychiatric disorder in patients on maintenance hemodialysis (MHD). It may contribute to poor prognosis in a number of ways, including its effect on platelet function. We aimed to investigate the impact and underlying mechanisms of depression on the occurrence of cardio-cerebral vascular events (CCVE) and dysfunction of arteriovenous fistula (DAVF) in MHD patients.

In this study, MHD patients were recruited and divided into depression and non-depression groups using the Hamilton Depression Scale (HAMD) in this prospective cohort study. Their clinical and laboratory indicators were collected and the occurrence of CCVE and DAVF were recorded through clinical follow-up, and analyzed, and the differences and possible influencing factors of CCVE and DAVF occurrence were assessed between the two groups of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2023-04-08
• Study Completion: 2023-05-31
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Patients had undergone dialysis treatment for more than 3 months, and their medical status was stable at the time of enrollment, with an expected survival period of more than 1 year

Exclusion Criteria

• (1) with communication disorders or mental illness other than depression; (2) a combination of cirrhosis, lymphoma, thrombocytopenic purpura, or other diseases that significantly affect platelet function; (3) complicated with malignant tumors, tuberculosis, severe heart failure, and unstable medical conditions; (4) inability or unwillingness to cooperate with researchers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depression group	depression	Patients will be assigned to the depression group if their score was ≥8.
Non-depression group	depression	The Hamilton Rating Scale for Depression (HAMD) will be applied to assess the depressive status of all enrolled patients. This scale consists of 24 survey items, each with a score of 0-4. Patients will be assigned to the nondepression group if their HAMD score was \<8.

Primary Outcome Measures

Name	Time	Method
cardio-cerebral vascular events (CCVE)	1 year	CCVEs were defined as the first occurrence of angina pectoris, myocardial infarction, episodes of heart failure requiring clinical intervention, arrhythmic episodes with clinically significant symptoms, transient ischemic attack, cerebral infarction, and cerebral hemorrhage during the observational period.
dysfunction of arteriovenous fistula (DAVF)	1 year	DAVF was diagnosed if a patient presented with any one or more of the following conditions that render his or her AVF unsatisfactory for effective hemodialysis: (1) loss of AVF murmur on clinical auscultation; (2) notable weakening or disappearance of pulsation in AVF; (3) echography showing interruption of blood flow, thrombosis within the internal fistula, or stenosis of the venous outflow tract at or near the anastomotic site; or (4) maximum blood flow \<200 mL/min in AVF during dialysis.

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China