Clinical trial NCT04304573: Is Correcting Total Serum Calcium Levels Important After Thyroidectomy
Official title: Is Correcting Total Serum Calcium Levels for Serum Albumin Necessary in Assessing Symptomatic Hypocalcemia After Total Thyroidectomy: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypocalcemia
Thyroid
Parathyroid Dysfunction
Calcium Disorder
Hormone Disturbance
Postoperative Complications
Keywords: hypocalcemia
total thyroidectomy
Payne's formula
ionized calcium
parathyroid hormone
predictive factor
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total thyroidectomy regardless of the surgical indication.

Brief summary: This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. The aim of this study is to determine whether total serum calcium level should be corrected for serum albumin in assessing symptomatic hypocalcemia after total thyroidectomy and which variable (total serum calcium, ionized calcium, corrected serum calcium for albumin with Payne's formula or early PTH) is the most valuable predictor of symptomatic hypocalcemia after total thyroidectomy.

Detailed description: This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020.The patients will be eligible if they undergo total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data are available through the first five postoperative days and if they sign an informed consent form. Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function will be excluded from the study.

Demographic and clinical data including age, sex, preoperative and postoperative laboratory values (total serum calcium, ionized calcium, corrected total serum calcium for serum albumin and PTH), neck dissection procedures, and postoperative calcium supplement therapy will be noted.

Primary outcome measures are presence of hypocalcemia on the first and fifth postoperative day. Secondary outcome measures are the need for calcium supplement therapy during the first five postoperative days, amount of medication given and correlation between presence of symptoms and low values of corrected total serum calcium levels. Preoperative blood samples for serum PTH and calcium measurements will be obtained after hospital admission. Postoperative serum PTH will be sampled 1 hour after surgery and at 7 am on the firstand fifth postoperative day. Serum calcium sampling will be performed daily if a patient has hypocalcemia detected on the first postoperative day. Hypocalcemia is defined as serum calcium levels \< 2.00 mmol/L regardless of clinical symptoms present. Normal PTH range is defined by the Department of Laboratory Diagnostics reference range - from 1.6 to 6.9 pmol/L. The recovery of parathyroid function is defined as the return of serum PTH and serum calcium to normal values, requiring no further calcium or vitamin D supplementation. If the patient does not have laboratory or clinical signs of hypocalcemia, calcium supplement therapy will not be administered. Supplement therapy will be administered in patients with laboratory findings confirming hypocalcemia. Supplement therapy consists of either peroral elemental calcium (calcium carbonate, 1-gram unit) or calcitriol (0.5 microgram unit) or both. If postoperative calcium and PTH are normal and there are no symptoms of discomfort, the patient will be discharged on the first or second postoperative day and serum PTH and calcium sampling will be performed on an outpatient basis. If the patient did not receive treatment during hospitalization, no supplements will be prescribed after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* The patients were eligible if they underwent total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data were available through the first five postoperative days and if they signed an informed consent form.

Exclusion Criteria:

* Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function were excluded from the study.

Primary outcomes:
measure: Corrected total serum calcium value
timeFrame: 5 days
Secondary outcomes:
measure: Administration of postoperative calcium supplement therapy
timeFrame: 5 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Sestre milosrdnice
Study officials:
affiliation: Department of Otorhinolaryngology and Head and Neck Surgery
name: Ivan Rašić, MD,PhD
role: STUDY_CHAIR
References: