UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056581 |
|---|---|
| Receipt number | R000063870 |
| Scientific Title | Kinetics and prognostic performance of serum renin concentration in critically ill hypotensive patients: a multicenter prospective cohort study |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2024/12/29 12:56:59 |
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Basic information
Public title
Temporal changes and outcome prediction of blood renin levels in patients with hypotension
Acronym
RICH study
Scientific Title
Kinetics and prognostic performance of serum renin concentration in critically ill hypotensive patients: a multicenter prospective cohort study
Scientific Title:Acronym
RICH study
Region
| Japan |
Condition
Condition
Shock
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To describe the kinetics of serum renin levels during the first 24 hours after vasopressor initiation in patients with hypotension treated in the intensive care unit (ICU).
2. To specify which renin value predicts 30-day mortality best among various variables deriving from six measurements during the 24 hours.
3. To visualize the trajectories of serum renin concentration and identify clinical phenotypes characterizing each trajectory.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
30-day mortality
Key secondary outcomes
1. ICU mortality
2. Major Adverse Kidney Events at day 30 (MAKE30)
3. Dependence on renal replacement therapy at day 30
4. Persistent renal dysfunction at day 30
5. Severe acute kidney injury at day 7
6. Days of alive and free from intravenous vasopressor therapy at day 30
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 meeting all of the following criteria will be included.
1. Admitted to the ICU within 24 hours
2. Aged 18 years or older
3. Requiring a continuous infusion of vasopressors (i.e., norepinephrine, vasopressin, epinephrine, phenylephrine, dopamine) to maintain the target blood pressure
4. Expected to stay in the ICU longer than 24 hours
Key exclusion criteria
Patients meeting either of the following criteria will be excluded.
1. History of primary or secondary aldosteronism
2. Active palliation
3. Pregnancy or lactation
4. Absence of informed consent from the study participant or their next of kin
5. Judgment of the treating physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kotani |
Organization
Kameda Medical Center
Division name
Department of Intensive Care Medicine
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
04-7092-2211
kotani.yuki@kameda.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kotani |
Organization
Kameda Medical Center
Division name
Department of Intensive Care Medicine
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
04-7092-2211
Homepage URL
kotani.yuki@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Yuki Kotani
Funding Source
Organization
Japanese Society of Intensive Care Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Japan
Tel
022-728-4105
ec@rinri.hosp.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
| 2025 | Year | 01 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Period
April 2025 (approval date)-June 2027
- Enrollment period: Until May 2026
- Follow-up period: Until June 2026
Inclusion Criteria
Participants must meet all of the following criteria:
1. Admitted to the ICU within 24 hours.
2. 18 years or older.
3. Receipt of continuous vasopressor infusion (norepinephrine, vasopressin, adrenaline, phenylephrine, or dopamine, alone or in combination).
4. Expected to stay in the ICU for more than 24 hours after enrollment.
Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
1. History of primary or secondary hyperaldosteronism.
2. Decision for aggressive palliative care.
3. Pregnancy or breastfeeding.
4. Decline to participate by the subject or their surrogate decision-maker.
5. Determination by the attending physician that study participation is inappropriate.
Study Design
A multicenter prospective cohort study.
Study Methods
This study targets adult patients in ICUs who require continuous intravenous infusion of vasopressors. Serum renin concentration will be measured six times within 24 hours of enrollment to elucidate its dynamics and validate its prognostic capability.
Primary Outcome
30-day mortality.
Secondary Outcomes
- ICU mortality.
- Major Adverse Kidney Events at 30 days (MAKE30: a composite outcome of mortality, dependency on renal replacement therapy [RRT], and persistent renal dysfunction).
- RRT dependency at 30 days.
- Persistent renal dysfunction at 30 days.
- Severe acute kidney injury within 7 days.
- Days alive and free from vasopressors at 30 days.
Statistical Analysis
Serum renin concentrations will be described as medians (interquartile ranges) at each measurement point. The main exposure variable will be the difference in serum renin concentration between 6 hours post-enrollment and baseline. Its association with the primary outcome, 30-day mortality, will be assessed using univariable and multivariable logistic regression analyses.
Management information
Registered date
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063870
