Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure

NCT06959927 | Completed

• 1 other identifier: No. DSYY-2024-26
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Age, hyperglycemia, inflammation, and comorbidities (hypertension, diabetes, coronary disease) independently increase HF risk in hemodialysis patients. Targeted risk management reduces psychological distress, complications, and enhances care outcomes.

Conditions

Hemodialysis; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiac Events (MACE) in Hemodialysis Patients with Heart Failure

  Composite endpoint including: Cardiovascular mortality (death due to heart failure, myocardial infarction, or arrhythmia). Hospitalization for worsening heart failure (requiring IV diuretics, vasodilators, or mechanical support). Dialysis-related cardiovascular complications (e.g., intradialytic hypotension, arrhythmias).

  From enrollment until first occurrence of any MACE component, assessed over 12 months.

Secondary Outcomes (5)

• Change in Inflammatory Biomarkers

  Baseline, 3 months, and 6 months.

• Glycemic Control Improvement

  Baseline and 6 months.

• Change in Psychological Distress (SAS/SDS Scores)

  Baseline, 6, 12, and 24 months

• Complication Rates

  Over 12 months.

• Nursing Satisfaction Score

  24 months

Other Outcomes (2)

• Biomarker Correlates (HbA1c, CRP)

  Baseline, 12, and 24 months

• Hospitalization Frequency

  24 months

Study Arms (2)

Standard Care Group

OTHER

Patients in this group received conventional hemodialysis care, including: Continuous monitoring of vital signs (blood pressure, respiratory rate, pulse, heart rhythm); Supplemental oxygen therapy as needed; Instruction on effective coughing techniques; Strict fluid and electrolyte management; Metabolic support therapies; Positional adjustments (upright posture with lower limb dependency); Environmental regulation (temperature: 22-24°C; humidity: 50-60%); Individualized dietary counseling.

Other: Standard Care Group

Risk-Stratified Management Group

OTHER

Patients in this group received standard care plus targeted risk management interventions: System Enhancement: Standardized nursing protocols and accountability frameworks Competency-based staff training (emergency response, fluid management) Individualized care plans (e.g., intensified glycemic control for diabetics, optimized BP monitoring for hypertensives) Risk Stratification: Admission assessments and follow-up evaluations to identify high-risk patients Hemodynamic monitoring with alert thresholds for early deterioration detection Strict pharmacological supervision and fluid balance protocols Environmental Modification: Optimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients Quality Control: Quarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies

Other: Risk-Stratified Management Group

Interventions

Standard Care Group OTHER

Patients in this group received conventional hemodialysis care, including: Continuous monitoring of vital signs (blood pressure, respiratory rate, pulse, heart rhythm); Supplemental oxygen therapy as needed; Instruction on effective coughing techniques; Strict fluid and electrolyte management; Metabolic support therapies; Positional adjustments (upright posture with lower limb dependency); Environmental regulation (temperature: 22-24°C; humidity: 50-60%); Individualized dietary counseling.

Standard Care Group

Risk-Stratified Management Group OTHER

Patients in this group received standard care plus targeted risk management interventions: System Enhancement: Standardized nursing protocols and accountability frameworks Competency-based staff training (emergency response, fluid management) Individualized care plans (e.g., intensified glycemic control for diabetics, optimized BP monitoring for hypertensives) Risk Stratification: Admission assessments and follow-up evaluations to identify high-risk patients Hemodynamic monitoring with alert thresholds for early deterioration detection Strict pharmacological supervision and fluid balance protocols Environmental Modification: Optimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients Quality Control: Quarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies

Risk-Stratified Management Group

Eligibility Criteria

• Age: 38 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were aged 18 years or older who had been undergoing regular hemodialysis treatment for more than three months.
• Patients were in good cardiopulmonary health without severe acute or chronic diseases, and were capable of undergoing the study-related examinations and treatments.
• Patients had not undergone major surgeries or experienced acute complications within the three months prior to enrollment, and their conditions were stable.
• Patients demonstrated high compliance by following medical advice and regularly attending dialysis sessions and related examinations.
• ⑤Patients were able to understand the study objectives, had signed the informed consent form, and were willing to cooperate with follow-up visits and long-term observation.

You may not qualify if:

• Patients were excluded if they had severe liver diseases (e.g., cirrhosis or liver failure), significant systemic infections, active tuberculosis, malignant tumors, connective tissue diseases, or other major illnesses.
• Patients with congenital kidney diseases, congenital heart defects, or other severe congenital structural abnormalities were excluded.
• Patients who had a documented history of severe cardiac diseases were excluded, including those with primary/secondary cardiomyopathy, valvular heart disease, myocarditis, or pericardial diseases.
• Patients were excluded if they had severe mental disorders or cognitive impairments that prevented their cooperation with study assessments or treatments.
• ⑤Patients whose clinical records or examination data were incomplete, thereby precluding effective analysis, were excluded.

Sponsors & Collaborators

• Guiren Hou: lead

Study Sites (1)

Changsha Fourth Hospital

Changsha, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Guiren Hou, MB

  Changsha Fourth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: May 7, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 30, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)