Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?

Thyroid Diseases Clinical Trial

Official title:

Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869398
• Other study ID #: 2017-048
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are performing this study to determine if supplementation with calcium and calcitriol (vitamin D) before surgery decreases the rate of hypocalcemia (low calcium) after surgery.

Postoperative hypocalcemia (low calcium) is the most common complication after thyroidectomy. Symptoms range from numbness/tingling around the mouth and fingers to severe problems such as low blood pressure, irregular heartbeat, muscle cramps and uncontrollable muscle spasms.

The current standard of practice at Lahey for patients undergoing total thyroidectomy is to start Tums 1500mg three times daily and Calcitriol 0.25mcg twice daily immediately after surgery. Also current practice is for each patient to have their calcium and albumin levels checked at 8 hours and 24 hours after surgery. If the corrected calcium level drops below 8.5 or they exhibit symptoms of hypocalcemia the dose of the Tums and Calcitriol are increased per protocol. All patients must also follow up in 3-4 days to have their calcium and albumin levels rechecked.

The investigators propose to change the above standard practice at Lahey by making only one change. The investigators wish to start Tums and Calcitriol 5 days before surgery, as opposed to after surgery. This will be the only change to the current standard of care at Lahey.

The investigators hypothesize that initiating Tums and Calcitriol supplementation in the preoperative period will decrease the overall rate of postoperative hypocalcemia and its related symptoms. This will possibly decrease length of hospital stay, decrease cost, and prevent any serious complications associated with low calcium.

Description:

The main objective of this study is to determine if treating patients with calcitriol and calcium prior to thyroidectomy decreases postoperative hypocalcemia. The primary outcome to be measured is clinical hypocalcemia, defined as peri-oral numbness and/or tingling, numbness and/or tingling in fingers, tetany, seizures, hypotension, palpitations. A secondary outcome measure of biochemical hypocalcemia will be measured. Biochemical hypocalcemia will be defined as a corrected calcium for albumin of less than 8.5 at 8 hours, 1 day, and 3 days postoperatively. Additional secondary outcome measures will be hospital length of stay, need for calcium gluconate IV supplementation, need for additional calcium monitoring.

Postoperative hypocalcemia is the most common complication after thyroidectomy. Symptoms range from perioral numbness/tingling and tingling in fingers to severe complications such as hypotension, arrhythmias and tetany. In prior studies hypocalcemia after thyroidectomy can occur up to 50% of the time. A retrospective cohort study from 2017 shows that treating patients with vitamin D and calcium preoperatively decreases the rate of postoperative hypocalcemia. Preoperative treatment in that study included calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID starting 5 days before surgery. This showed a significant decrease in postoperative hypocalcemia, decreased hospital stay, and overall decrease in cost for patients undergoing total thyroidectomy. This study was limited by its retrospective and observational nature. By performing a prospective randomized study on preoperative supplementation the investigators hope to provide a stronger level of evidence to support this practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients, age >18, undergoing total thyroidectomy are eligible.

Exclusion Criteria:

• partial thyroidectomy, lobectomy, or concurrent parathyroidectomy.

Related Conditions & MeSH terms

• Hypocalcemia
• Thyroid Diseases

Intervention

Dietary Supplement:
• Tums
start their calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID 5 days before surgery. The five days is determined due to the time it takes vitamin D to have an effect on the guts reabsorption of calcium.
• Calcitriol
start their calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID 5 days before surgery. The five days is determined due to the time it takes vitamin D to have an effect on the guts reabsorption of calcium.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (8)

Docimo G, Ruggiero R, Casalino G, Del Genio G, Docimo L, Tolone S. Risk factors for postoperative hypocalcemia. Updates Surg. 2017 Jun;69(2):255-260. doi: 10.1007/s13304-017-0452-x. Epub 2017 Apr 25. — View Citation

Falk SA, Birken EA, Baran DT. Temporary postthyroidectomy hypocalcemia. Arch Otolaryngol Head Neck Surg. 1988 Feb;114(2):168-74. — View Citation

Iglesias P, Díez JJ. Endocrine Complications of Surgical Treatment of Thyroid Cancer: An Update. Exp Clin Endocrinol Diabetes. 2017 Sep;125(8):497-505. doi: 10.1055/s-0043-106441. Epub 2017 Apr 25. Review. — View Citation

Maxwell AK, Shonka DC Jr, Robinson DJ, Levine PA. Association of Preoperative Calcium and Calcitriol Therapy With Postoperative Hypocalcemia After Total Thyroidectomy. JAMA Otolaryngol Head Neck Surg. 2017 Jul 1;143(7):679-684. doi: 10.1001/jamaoto.2016.4796. — View Citation

Pattou F, Combemale F, Fabre S, Carnaille B, Decoulx M, Wemeau JL, Racadot A, Proye C. Hypocalcemia following thyroid surgery: incidence and prediction of outcome. World J Surg. 1998 Jul;22(7):718-24. Review. — View Citation

Reeve T, Thompson NW. Complications of thyroid surgery: how to avoid them, how to manage them, and observations on their possible effect on the whole patient. World J Surg. 2000 Aug;24(8):971-5. Review. — View Citation

Roh JL, Park CI. Routine oral calcium and vitamin D supplements for prevention of hypocalcemia after total thyroidectomy. Am J Surg. 2006 Nov;192(5):675-8. — View Citation

Testa A, Fant V, De Rosa A, Fiore GF, Grieco V, Castaldi P, Persiani R, Rausei S, D'ugo D, De Rosa G. Calcitriol plus hydrochlorothiazide prevents transient post-thyroidectomy hypocalcemia. Horm Metab Res. 2006 Dec;38(12):821-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Hypocalcemia	The main objective of this study is to determine if treating patients with calcitriol and calcium prior to thyroidectomy decreases postoperative hypocalcemia. The primary outcome to be measured is clinical hypocalcemia, defined as peri-oral numbness and/or tingling, numbness and/or tingling in fingers, tetany, seizures, hypotension, palpitations	3 days post operative
Secondary	Biochemical hypocalcemia	A secondary outcome measure of biochemical hypocalcemia will be measured. Biochemical hypocalcemia will be defined as a corrected calcium for albumin of less than 8.5 at 8 hours, 1 day, and 3 days postoperatively	3 days post operative
Secondary	Length of stay	hospital length of stay	3 days post operative