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

Sponsor

First Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT06070805

Collaborator

(none)

286

Enrollment

Location

15.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardio-cerebral Vascular Events Arteriovenous Fistula Dysfunction	Other: depression

Study Design

Study Type:

Observational

Actual Enrollment :

286 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in Hemodialysis Patients: A Single Center and Real-world Study

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Apr 8, 2023

Actual Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Non-depression group 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.	Other: depression The score of Hamilton Rating Scale for Depression (HAMD) is ≥8
Depression group Patients will be assigned to the depression group if their score was ≥8.	Other: depression The score of Hamilton Rating Scale for Depression (HAMD) is ≥8

Arm

Intervention/Treatment

Non-depression group

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.

Other: depression

The score of Hamilton Rating Scale for Depression (HAMD) is ≥8

Depression group

Patients will be assigned to the depression group if their score was ≥8.

Other: depression

The score of Hamilton Rating Scale for Depression (HAMD) is ≥8

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.