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

NCT ID: NCT06959927

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-01-30

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.

Conditions

Hemodialysis; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Care Group

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.

Group Type: OTHER

Standard Care Group

Intervention Type: 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

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

Group Type: OTHER

Risk-Stratified Management Group

Intervention Type: 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

Interventions

Standard Care Group

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.

Intervention Type: OTHER

Risk-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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guiren Hou

OTHER_GOV

Sponsor Role: lead

Responsible Party

Guiren Hou

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guiren Hou, MB

Role: PRINCIPAL_INVESTIGATOR

Changsha Fourth Hospital

Locations

Changsha Fourth Hospital

Changsha, , China

Countries

China

Other Identifiers

No. DSYY-2024-26

Identifier Type: -

Identifier Source: org_study_id