UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062725 |
|---|---|
| Receipt number | R000069592 |
| Scientific Title | Perioperative Serum Potassium Levels in Patients Receiving Licorice-Containing Kampo Medicines: A Retrospective Study. |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/28 15:04:17 |
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Basic information
Public title
A study investigating potassium levels in surgical patients taking Kampo medicines containing licorice.
Acronym
KLK study
Scientific Title
Perioperative Serum Potassium Levels in Patients Receiving Licorice-Containing Kampo Medicines: A Retrospective Study.
Scientific Title:Acronym
KLK study
Region
| Japan |
Condition
Condition
Patients who regularly received licorice-containing Kampo medicines from the preoperative period until the day before surgery.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Anesthesiology |
| Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to retrospectively evaluate perioperative changes in serum potassium levels in patients regularly taking licorice-containing Kampo medicines before surgery, to determine the incidence of hypokalemia, and to identify factors that may contribute to the risk assessment of hypokalemia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of perioperative hypokalemia (defined as serum potassium <3.5 mEq/L).
Key secondary outcomes
Minimum perioperative serum potassium level
Change in serum potassium from preoperative value to perioperative nadir
Incidence of hypokalemia stratified by severity
Risk factors for hypokalemia
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
| 19 | years-old | <= |
Age-upper limit
| 130 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who regularly received licorice-containing Kampo medicines from the preoperative period until the day before surgery.
Key exclusion criteria
Patients without intraoperative serum potassium measurements, patients younger than 18 years of age, patients receiving dialysis, patients with ileus, and patients undergoing emergency surgery.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Mori |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Anesthesia
Zip code
1528902
Address
Tokyo Meguro Higashi-gaoka 2-5-1
TEL
03-3411-0111
yosuke@mori.name
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Mori |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Anesthesia
Zip code
1528902
Address
Tokyo Meguro Higashi-gaoka 2-5-1
TEL
03-3411-0111
Homepage URL
yosukemoriyosuke@gmail.com
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Yosuke Mori
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka Meguro Tokyo
Tel
03-3411-0111
yosukemoriyosuke@gmail.com
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
東京医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
103
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 08 | Month | 31 | Day |
Other
Other related information
Patients who met the inclusion criteria were identified, and clinical data were collected from the surgical management system and electronic medical records.
Collected variables included demographic characteristics, surgical information, and perioperative laboratory data, including age, sex, height, weight, preoperative medications, surgical diagnosis, surgical procedure, preoperative, intraoperative, and postoperative serum potassium levels, sampling time, blood gas parameters pH, base excess, PaCO2, and HCO3, preoperative creatinine level, comorbidities, albumin level, and hemoglobin level.
For statistical analysis, patient characteristics and perioperative data were summarized using descriptive statistics. Continuous variables were expressed as mean and standard deviation, and categorical variables as frequencies.
The primary analysis described the incidence of perioperative hypokalemia and the distribution of serum potassium levels.
Secondary analyses evaluated the association between changes in serum potassium levels and clinical background factors. In addition, multivariable logistic regression analysis was performed to explore risk factors for hypokalemia.
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069592
