UMIN-CTR Clinical Trial

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
Email	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
Email	holy197741@me.com

Sponsor
Institute	Nagasaki University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039194