UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045386 |
|---|---|
| Receipt number | R000051827 |
| Scientific Title | Relationship between hemodynamic instability and glycocalyx in patients requiring continuous renal replacement therapy: a single-center prospective observational study |
| Date of disclosure of the study information | 2021/09/27 |
| Last modified on | 2025/09/09 11:23:02 |
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Basic information
Public title
Relationship between hemodynamic instability and glycocalyx in patients requiring continuous renal replacement therapy: a single-center prospective observational study
Acronym
Relationship between hemodynamic instability and glycocalyx in patients requiring continuous renal replacement therapy: a single-center prospective observational study
Scientific Title
Relationship between hemodynamic instability and glycocalyx in patients requiring continuous renal replacement therapy: a single-center prospective observational study
Scientific Title:Acronym
Relationship between hemodynamic instability and glycocalyx in patients requiring continuous renal replacement therapy: a single-center prospective observational study
Region
| Japan |
Condition
Condition
Patients requiring continuous renal replacement therapy
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between hemodynamic instability and endothelial glycocalyx injury at the time of induction or circuit changes of renal replacement therapy in patients requiring continuous renal replacement therapy.
Basic objectives2
Others
Basic objectives -Others
This study evaluates glycocalyx from the values of syndecan-1 blood concentration before the introduction of continuous renal replacement therapy and circuit replacement. In addition, the hemodynamics at the time of introduction of continuous renal replacement therapy and circuit exchange will be evaluated, and the relationship with glycocalyx will be investigated.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of the blood concentration of syndecan-1, which is a component of glycocalyx, between those before the introduction or circuit changes and thereafter.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiring continuous renal replacement therapy at Department of Emergency and Critical Care Medicine,Tohoku University Hospital
Key exclusion criteria
1) Patients with malignant tumors
2) Patients without invasive arterial pressure monitoring
3) Patients being judged to be inappropriate for participation by attending physicians.
4) patients who used percutaneous cardiopulmonary support
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Kushimoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi,Aoba-ku,Sendai ,980-8574,Japan
TEL
+81-22-717-7489
kussie@emergency-medicine.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Ogasawara |
Organization
Tohoku University Graduate School of Medicine
Division name
Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi,Aoba-ku,Sendai ,980-8574,Japan
TEL
+81-22-717-7688
Homepage URL
ryota.ogasawara.e1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Departmental funds of Division of Emergency and Critical Care Medicine,Tohoku University Graduate School of Medicine
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi,Aoba-ku,Sendai,980-8574,Japan
Tel
+81-22-728-4105
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
53
Results
Excluding excluded cases, 37 patients were included in the analysis: 15 patients (40.5%) who HIRRT and 22 patients (59.5%) who did not. There was no significant difference in the change in syndecan-1 levels between the HIRRT and non-HIRRT groups (p=0.89). However, multivariate linear regression analysis using age, sex, SOFA score, and the presence or absence of maintenance dialysis revealed a significant association between the change in syndecan-1 levels and the occurrence of HIRRT (p=0.004).
Results date posted
| 2025 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no differences between the two groups in terms of age, sex, height, weight, Body Mass Index, pH, lactate level, white blood cell count, C-reactive protein, catecholamine index, SOFA score, length of hospital stay, duration of CRRT, in-hospital mortality rate, sepsis, severe heart failure, or presence of mechanical ventilation.
In the HIRRT group, the majority of cases were due to sepsis, while in the non-HIRRT group, sepsis and cardiopulmonary arrest (CPA) were the most common causes. Creatinine levels at the time of CRRT initiation were lower in the HIRRT group (3.05 [2.63 - 6.09] mg/dL vs. 6.09 [4.04 - 8.2] mg/dL, p = 0.016).
Participant flow
Of the 53 patients who were enrolled, 37 were included in the analysis. The following patients were excluded: those with malignancy (1 patient), those who used a percutaneous cardiopulmonary support device (3 patients), those for whom blood samples could not be collected (6 patients), those who discontinued CRRT partway through the study (3 patients), and those who died and discontinued CRRT during the evaluation period (3 patients).
Adverse events
N/A
Outcome measures
Group Comparison of Syndecan-1 Change by HIRRT
There was no significant difference in the change in syndecan-1 levels between the HIRRT and non-HIRRT groups (-62.2 [-83.6 - 11.7] ng/mL vs. -32.3 [-640.6 - 22.5] ng/mL, p = 0.89).
Multivariate Linear Regression Analysis for Factors Influencing Syndecan-1
A multivariate linear regression analysis was performed with the change in syndecan-1 levels as the dependent variable and factors considered to influence it as independent variables. The following were identified as significant factors: the occurrence of HIRRT (estimate 152.3, 95% confidence interval [53.2 - 251.4], p = 0.004), age (estimate 9.27, 95% confidence interval [2.66 - 15.9], p = 0.008), SOFA score (estimate -59.3, 95% confidence interval [-87.5 - -31.0], p < 0.001), and maintenance dialysis patients (estimate -176.8, 95% confidence interval [-280.2 - -73.5], p = 0.002).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Patient enrollment period:from October 2021 to March 2023.
Blood concentration of syndecan-1 is measured by ELISA. Other data will be collected from the electronic medical record and intensive care monitoring/recording system.
Management information
Registered date
| 2021 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051827
