UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034377 |
|---|---|
| Receipt number | R000039194 |
| Scientific Title | Study to clarify the mechanism of developing hyperkalemia due to hypothyroidism in thyroidectomized patients undergoing thyroid hormone withdrawal for radioactive iodine therapy. |
| Date of disclosure of the study information | 2018/10/04 |
| Last modified on | 2021/04/14 13:13:55 |
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Basic information
Public title
Study to clarify the mechanism of developing hyperkalemia due to hypothyroidism in thyroidectomized patients undergoing thyroid hormone withdrawal for radioactive iodine therapy.
Acronym
Hyperkalemia in hypothyroidism
Scientific Title
Study to clarify the mechanism of developing hyperkalemia due to hypothyroidism in thyroidectomized patients undergoing thyroid hormone withdrawal for radioactive iodine therapy.
Scientific Title:Acronym
Hyperkalemia in hypothyroidism
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study to clarify what determine to develop hyperkalemia in patients with thyroid cancer undergoing thyroid hormone withdrawal in preparation for radioactive iodine therapy.
Basic objectives2
Others
Basic objectives -Others
exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Levels of serum potassium, and plasma rennin activity, aldosterone, cortisol, ACTH, ADH.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Thyroidectomized patients with thyroid cancer who admitted to Nagasaki University Hospital to take radioactive iodine therapy with undergoing thyroid hormone withdrawal.
Key exclusion criteria
Patients administered with diuretic drug, ACE inhibitor, ARB, or steroid hormone.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
Sakamoto1-7-1, Nagasaki
TEL
0958197200
holy197741@me.com
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
Sakamoto1-7-1, Nagasaki
TEL
0958197200
Homepage URL
holy197741@me.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Nagasaki University Hospital Clinical Study Review Board
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7200
holy197741@me.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31652100/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31652100/
Number of participants that the trial has enrolled
46
Results
Acute hypothyroidism can cause a significant increase in the serum potassium level, which may be associated with a decreased eGFR and decreased circulating RAS.
Results date posted
| 2021 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were the thyroidectomized patients with thyroid carcinoma to undergo radioactive iodine treatment. All patients were normokalemic before levothyroxine withdrawal.
Participant flow
We conducted a single-center, prospective cohort study of 46 Japanese patients with thyroid carcinoma undergoing levothyroxine withdrawal prior to radioiodine therapy.
Adverse events
None
Outcome measures
Blood samples were analyzed 3 times: before, and at 3 and 4 weeks after levothyroxine withdrawal. We investigated factors that may be associated with the elevation of serum potassium levels from a euthyroid state to a hypothyroid state.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 01 | Day |
Other
Other related information
Explore to the factors of developing hyperkalemia in acute hypothyroidism.
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039194
