- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351451
Hypomagnesemia and Hypocalcemia Association Following Thyroidectomy
Magnesium plays a role in the active transport of calcium (Ca+2) and potassium ions across cell membranes. Most of it is intracellular or in the bone , however less than 1% of magnesium is in the blood serum. Hypoparathyroidism post thyroidectomy leads to acute Hypocalcemia that leads to hypomagnesemia. The relation of Ca+2 and magnesium (Mg+2) metabolism is complex and mainly related to the interaction of these cations with parathyroid post thyroidectomy. (Mg+2) is an essential regulator of Ca+2 flux and intracellular action of Ca+2. Hypomagnesaemia impairs hypocalcaemia induced PTH release, which is corrected rapidly after magnesium replacement. Attempting to correct only hypocalcemia may prolong symptoms. It is important to monitor both Ca+2 & Mg+2 levels following thyroidectomy to facilitate prompt resolution of symptoms.
Aim of the study: is to highlight the prevalence of hypomagnesemia following thyroidectomy and its association with hypocalcemia which mandate early recognition and treatment to prevent prolongation of hypocalcemia and permanent hypoparathyroidism
Methods:
IRB obtained (E20-4615) informed consent taken from all patient. This is prospective open Label observational study in patients underwent thyroidectomy .the study period was from January 2019 to January 2020. Total of 74 patients with normal renal function. Corrected serum Ca+2, magnesium, phosphate level and vitamin D level are all checked pre operatively and in the first post-operative day.
Result:
Post thyroidectomy 56.8% of patients had hypomagnesemia. 59.5.1% patients had hypocalcemia and 41.9% of patients had low both Ca+2 and Mg+2 (P=0.004)
Conclusion:
Hypocalcemia and hypomagnesemia following thyroidectomy is of multi factorial related mainly to Ca+2, Mg+2 interaction.
Keywords: Hypomagnesemia. Hypocalcemia. Thyroidectomy
Study Overview
Status
Intervention / Treatment
Detailed Description
Methods:
A prospective study for 1 year starting 1/1/2019 to 1/1/2020. A total 74 patients with normal renal function .admitted for thyroidectomy. Preoperative serum calcium, magnesium, phosphate and vitamin D level all checked. Postoperatively corrected serum calcium, magnesium and phosphate level are checked. The serum calcium less than 2.12mmol/l is corrected with oral or IV calcium infusion plus vitamin D depending on the severity of symptoms. Any serum magnesium less than 0.75mmol/l is corrected with infusion magnesium sulfate. Calcium and magnesium level monitored and corrected according to the result.
Statistical analysis:
Statistical analysis was performed using statistical package for the social sciences (SPSS) version 23.0 software (SPSS Inc., Chicago ,IL,USA). If normal distributed, continuous variable were presented as mean (SD) Student t-test for paired observation was used for statistical. Pearson Chi-square test was used to compare the percentage for categorical variables. P less than 0.05 indicate statistically significant difference
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Central Region
-
Riyadh, Central Region, Saudi Arabia, 11352
- College of Medicine , King Saud University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
all patients admitted for thyroidectomy -
Exclusion Criteria:
patient with renal disease
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hypomagnesemia post thyroidectomy
Time Frame: one year period
|
magnesium serum level less than 0.75 mmol/l
|
one year period
|
|
Hypocalcemia post thyroidectomy
Time Frame: one year period
|
calcium serum level less than 2.12 mmol/l
|
one year period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
association of Hypomagnesemia and Hypocalcemia
Time Frame: one year period
|
calculate the percentage of association of both metabolic derangement post thyroidectomy
|
one year period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 42CFR Part11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypocalcemia
-
Hospital Universitari de BellvitgeRecruitingIatrogenic HypocalcemiaSpain
-
Instituto PalaciosNexentia S.A.S.CompletedHypocalcemia; DietarySpain
-
Al Safwa University CollegeCompletedHypocalcemia After Total ThyroidectomyTunisia
-
Siriraj HospitalActive, not recruitingHypocalcemia in PregnancyThailand
-
Istanbul UniversityUnknownHypocalcemia, Postoperative ParathormoneTurkey
-
Gulab Devi HospitalCompletedHypocalcemia | Hypocalcemia After Total ThyroidectomyPakistan
-
G. Hatzikosta General HospitalUnknownHypocalcemia After Total ThyroidectomyGreece
-
King Edward Medical UniversityMayo Hospital LahoreNot yet recruitingPostoperative Symptomatic Hypocalcemia Following Total ThyroidectomyPakistan
-
Radboud University Medical CenterCompletedHypomagnesemia, Intestinal, With Secondary Hypocalcemia | Drug Induced Hypomagnesemia
-
Calcilytix Therapeutics, Inc., a BridgeBio companyCompletedAutosomal Dominant Hypocalcemia (ADH) | Autosomal Dominant Hypocalcemia Type 1 (ADH1)United States
Clinical Trials on thyroidectomy
-
Aristotle University Of ThessalonikiAHEPA University HospitalCompleted
-
Shahida Islam Medical ComplexCompleted
-
Second Military Medical UniversityUnknown
-
Assiut UniversityUnknown
-
Kahramanmaras Sutcu Imam UniversityCompletedThyroid Diseases | Thyroid Cancer | Thyroid Nodule | Thyroid Neoplasms Benign
-
Centre Hospitalier Universitaire de NīmesTerminatedGraves Disease | Goiter | Thyroid Nodule | ThyroiditisFrance
-
University of AlbertaTerminated
-
Sohag UniversityRecruitingBenign Thyroid DiseasesEgypt
-
University of Colorado, DenverCharite University, Berlin, GermanyTerminatedHypothyroidism | Postsurgical HypothyroidismUnited States
-
Tel-Aviv Sourasky Medical CenterCompletedPapillary Thyroid Cancer | Well Differentiated Thyroid Carcinoma