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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06959927
Enrollment
170
Registered
2025-05-07
Start date
2022-01-01
Completion date
2024-01-30
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Heart Failure

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.

Detailed description

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.

Interventions

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.

OTHERRisk-Stratified Management Group

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

Sponsors

Guiren Hou
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
38 Years to 68 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Major Adverse Cardiac Events (MACE) in Hemodialysis Patients with Heart FailureFrom 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

MeasureTime frameDescription
Change in Inflammatory BiomarkersBaseline, 3 months, and 6 months.Reduction in serum C-reactive protein (CRP) and interleukin-6 (IL-6) levels from baseline to 6 months.
Glycemic Control ImprovementBaseline and 6 months.Absolute change in glycated hemoglobin (HbA1c) levels in diabetic patients.
Change in Psychological Distress (SAS/SDS Scores)Baseline, 6, 12, and 24 monthsReduction 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)
Complication RatesOver 12 months.Incidence of dialysis-related complications (hypotension, pulmonary edema, infections).
Nursing Satisfaction Score24 monthsPatient-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

MeasureTime frameDescription
Biomarker Correlates (HbA1c, CRP)Baseline, 12, and 24 monthsAssociation between baseline HbA1c (\>5.7%)/CRP (\>3 mg/L) and HF incidence.
Hospitalization Frequency24 monthsAll-cause and HF-related hospital admissions.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026