UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058995 |
|---|---|
| Receipt number | R000067134 |
| Scientific Title | Prognostic validity of mean arterial pressure to norepinephrine equivalent dose ratio for mortality in critically ill patients: a single-center retrospective cohort study |
| Date of disclosure of the study information | 2025/09/04 |
| Last modified on | 2025/09/04 17:31:29 |
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Basic information
Public title
Prognostic validity of blood pressure to vasopressor ratio in shock: a single-center retrospective cohort study
Acronym
Blood pressure to vasopressor ratio in shock
Scientific Title
Prognostic validity of mean arterial pressure to norepinephrine equivalent dose ratio for mortality in critically ill patients: a single-center retrospective cohort study
Scientific Title:Acronym
Mean arterial pressure to vasopressor ratio in shock
Region
| Japan |
Condition
Condition
Shock
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognostic validity of mean arterial pressure to norepinephrine equivalent dose ratio in patients with shock.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospital mortality
Key secondary outcomes
Intensive care unit mortality
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
All adult patients (18 years or older), who received a continuous infusion of norepinephrine base of 5 mcg/min or greater within the first 24 hours after ICU admission between November 2, 2020 and June 30, 2024.
Key exclusion criteria
We excluded patients who stayed in the ICU for less than 24 hours, patients undergoing mechanical circulatory support (venoarterial extracorporeal membrane oxygenation, intraaortic balloon pumping, microaxial flow pump, ventricular assist device), patients without invasive arterial blood pressure monitoring, and patients who opted out of this study.
Target sample size
900
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
2968602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
0470922211
dkivoar287@gmail.com
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
2968602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
0470922211
Homepage URL
dkivoar287@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Yuki Kotani
Funding Source
Organization
Department funding only
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical review board of Kameda Medical Center
Address
929 Higashi-cho, Kamogawa 2968602, Japan
Tel
0470922211
clinical_research@kameda.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 | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
937
Results
Under preparation
Results date posted
| 2025 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Under preparation
Participant flow
Under preparation
Adverse events
None
Outcome measures
Under preparation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Categorical variables will be summarized as frequencies and percentages and will be compared using the chi-squared test or Fisher's exact test, as appropriate. Continuous variables will be expressed as medians with interquartile ranges and will be compared using the Wilcoxon rank-sum test.
To assess the construct validity of the lowest mean arterial pressure to norepinephrine equivalent dose ratio, we will first compare hospital mortality across its tertiles. We will then examine the association between mean arterial pressure/norepinephrine equivalent dose ratio tertiles and mortality at hospital and intensive care unit discharge using multivariable logistic regression analysis. The regression models will be adjusted for the following covariates: age, sex, Charlson comorbidity index, presence of sepsis or septic shock at ICU admission, emergency admission status, mechanical ventilation within the first 24 hours, and renal replacement therapy within the first 24 hours. These covariates will be selected based on clinical relevance.
Next, we will evaluate the prognostic validity of the mean arterial pressure/norepinephrine equivalent dose ratio for hospital and intensive care unit mortality by comparing it with the lowest mean arterial pressure and highest norepinephrine equivalent dose, using restricted cubic spline models. To compare their discriminative performance, we will conduct logistic regression analyses and will calculate the area under the receiver operating characteristic curve. Additionally, we will perform a subgroup analysis focusing on patients with sepsis or septic shock.
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067134
