Chronic Kidney Disease(CKD),maintenance dialysis
Conditions
Interventions
None listed
Sponsors
CHUBU UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: As this study is exploratory in nature, we set the target sample size at 100 patients (or 100 dialysis sessions) based on the number that could be feasibly recruited during the study period. In routine dialysis treatment, the proportion of patients who experience adverse events, such as sudden drops in blood pressure or vomiting, is expected to be only a few percent, assuming that dialysis is performed safely. However, this study requires collecting data from patients who experience or are suspected to experience deterioration during dialysis. Analyzing such data is crucial for exploring ways to prevent adverse events and ensure safer dialysis treatment. Additionally, due to the lack of prior research using esCCO data from patients who have undergone dialysis without complications, accumulating such data during treatment is of significant value. Considering the need for statistical analysis of various parameters, we determined that a sample size of 100 patients (or 100 dialysis sessions) is appropriate.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1) Patients with supraventricular arrhythmias, such as atrial fibrillation, atrial flutter, or sinus arrhythmia, that were present prior to the initiation of dialysis. 2) Patients with frequent premature contractions, such as bigeminy or trigeminy. 3) Patients with implanted pacemakers. 4) Patients who may become agitated due to sensor attachment could potentially compromise the safety of dialysis treatment. 5) Patients whose consent cannot be clearly confirmed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart Rate(HR), Non invasive Blood Pressure(NIBP), Percutaneous Arterial Oxygen Saturation(SpO2), Respiratory Rate(RR), Estimated Continuous Cardiac Output(esCCO), Estimated Continuous Cardiac Index(esCCI), Estimated Stroke Volume(esSV), Estimated Stroke Volume Index(esSVI), Pulse Amplitude Index(PI), Systemic Vascular Resistance(SVR), Systemic Vascular Resistance Index(SVRI), Delta Blood Volume(Delta BV) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient demographics, including age and underlying diseases Dialysis history Dialysis parameters, such as ultrafiltration volume and ultrafiltration rate Patient events during dialysis, such as yawning, vomiting, and loss of consciousness Occurrence of adverse events Yawning, although seemingly benign, can be observed as a prodromal symptom of circulatory compromise, potentially indicating early signs of intradialytic hypotension or reduced cerebral perfusion. | — |
Countries
Japan
Contacts
Public ContactKoji Nakai
CHUBU UNIVERSITY College of Life and Health Sciences Department of Clinical Engineering
Outcome results
None listed