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Completed

NCT Number: NCT06959927

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

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.

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Key information

Conditions

Hemodialysis Cardiovascular Diseases Heart Diseases Heart Failure

Age range

38 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changsha Fourth Hospital

Changsha, China

About this study

To identify risk factors for heart failure (HF) in hemodialysis patients and assess the efficacy of targeted risk management strategies in improving prognosis and care quality. A total of 170 hospitalized dialysis patients from January 2022 to January 2024 were enrolled. They were divided into two groups based on the presence or absence of heart failure: the heart failure group (n=80) and the non-heart failure group (n=90). The inducing factors were analyzed, and targeted risk management strategies were implemented, with the participants further divided into a conventional group (n=40) and a study group (n=40) to explore the effect of these strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Change in Inflammatory Biomarkers

    Time frame: Baseline, 3 months, and 6 months.

    Reduction in serum C-reactive protein (CRP) and interleukin-6 (IL-6) levels from baseline to 6 months.

  2. Glycemic Control Improvement

    Time frame: Baseline and 6 months.

    Absolute change in glycated hemoglobin (HbA1c) levels in diabetic patients.

  3. Change in Psychological Distress (SAS/SDS Scores)

    Time frame: Baseline, 6, 12, and 24 months

    Reduction in anxiety/depression scores post-intervention:

    Self-rating Anxiety Scale (SAS; range 0-100, higher = worse)

    Self-rating Depression Scale (SDS; range 0-100, higher = worse)

  4. Complication Rates

    Time frame: Over 12 months.

    Incidence of dialysis-related complications (hypotension, pulmonary edema, infections).

  5. Nursing Satisfaction Score

    Time frame: 24 months

    Patient-reported satisfaction (25-item Likert scale; 1-4 per item, total 25-100; higher = better), categorized as:

    Very satisfied (>90)

    Satisfied (70-90)

    Dissatisfied (<70)

Other outcomes

  1. Biomarker Correlates (HbA1c, CRP)

    Time frame: Baseline, 12, and 24 months

    Association between baseline HbA1c (>5.7%)/CRP (>3 mg/L) and HF incidence.

  2. Hospitalization Frequency

    Time frame: 24 months

    All-cause and HF-related hospital admissions.

Sponsors and collaborators

Lead sponsor

Guiren Hou

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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