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

NCT06070805 | Completed

• 1 other identifier: 1st ChongqingMU
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardio-cerebral Vascular Events; Arteriovenous Fistula Dysfunction

Keywords

maintenance hemodialysis patients; depression; cardio-cerebral vascular events; arteriovenous fistula dysfunction; platelet

Outcome Measures

Primary Outcomes (2)

• cardio-cerebral vascular events (CCVE)

  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.

  1 year

• dysfunction of arteriovenous fistula (DAVF)

  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.

  1 year

Study Arms (2)

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

Depression group

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

Other: depression

Interventions

depression OTHER

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

Depression group; Non-depression group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing maintenance hemodialysis were recruited from the First Affiliated Hospital of Chongqing Medical University in China.

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Yunfeng Xia, Dr

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: February 1, 2022
• Primary Completion: April 8, 2023
• Study Completion: May 31, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

CN (1)