UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058809 |
|---|---|
| Receipt number | R000065572 |
| Scientific Title | Assessment of the Invasiveness of Dialysis Therapy Using Estimated Continuous Cardiac Output Monitoring |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/15 16:55:06 |
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Basic information
Public title
Assessment of the Invasiveness of Dialysis Therapy Using Estimated Continuous Cardiac Output Monitoring
Acronym
Assessment of the Invasiveness of Dialysis Therapy Using Estimated Continuous Cardiac Output Monitoring
Scientific Title
Assessment of the Invasiveness of Dialysis Therapy Using Estimated Continuous Cardiac Output Monitoring
Scientific Title:Acronym
Assessment of the Invasiveness of Dialysis Therapy Using Estimated Continuous Cardiac Output Monitoring
Region
| Japan |
Condition
Condition
Chronic Kidney Disease(CKD),maintenance dialysis
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dialysis therapy, while essential for managing end-stage renal disease (ESRD) in patients with chronic kidney disease (CKD), can be physiologically invasive due to the rapid changes it induces in the internal environment over a short period of time. One of the common complications during dialysis is intradialytic hypotension (IDH). Sudden drops in blood pressure during dialysis have been associated with poor clinical outcomes. Therefore, there is a growing demand for monitoring devices capable of early detection of blood pressure drops and prompt notification to medical personnel.
In this study, we aim to collect and analyze various hemodynamic parameters in dialysis patients using dialysis session data and non-invasive estimated continuous cardiac output (esCCO). Through this analysis, we seek to evaluate the circulatory changes caused by dialysis therapy from a multidimensional perspective and better understand its physiological impact.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nakai |
Organization
CHUBU UNIVERSITY
Division name
College of Life and Health Sciences Department of Clinical Engineering
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi 487-8501, JAPAN
TEL
0568-51-1111
k_nakai@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Nakai |
Organization
CHUBU UNIVERSITY
Division name
College of Life and Health Sciences Department of Clinical Engineering
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi 487-8501, JAPAN
TEL
0568-51-1111
Homepage URL
k_nakai@fsc.chubu.ac.jp
Sponsor or person
Institute
CHUBU UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
CHUBU UNIVERSITY
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi 487-8501, JAPAN
Tel
0568-51-1111
k_nakai@fsc.chubu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
S2024-#007
Org. issuing International ID_1
Shinseikai Daiichi Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新生会第一病院（愛知県名古屋市）、新生会クリニック（愛知県名古屋市）、東海クリニック（愛知県東海市）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study, Centralized ethical approval by the Chubu University Ethics Review Committee(Approval Number: 20240032-3; Date of Approval: April 17, 2025, Approval Period: April 17, 2025-March 31, 2027).
Management information
Registered date
| 2025 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065572
