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

NCT03869398 | Completed DMC

• 1 other identifier: 2017-048
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypocalcemia; Thyroid Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Biochemical hypocalcemia

  3 days post operative

• Length of stay

  3 days post operative

Study Arms (2)

Control arm: No pre-op medications

NO INTERVENTION

patients undergoing total thyroidectomy are started on calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID immediately postoperatively. No pre-operative medications are given

Intervention arm: Tums and Calcitriol pre-op

EXPERIMENTAL

patients start 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.

Dietary Supplement: Tums; Dietary Supplement: Calcitriol

Interventions

Tums DIETARY_SUPPLEMENT

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.

Intervention arm: Tums and Calcitriol pre-op

Calcitriol DIETARY_SUPPLEMENT

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.

Intervention arm: Tums and Calcitriol pre-op

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• partial thyroidectomy, lobectomy, or concurrent parathyroidectomy.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related Publications (9)

• 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. doi: 10.1055/s-2006-956504.

  PMID: 17163358 BACKGROUND

• 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. doi: 10.1016/j.amjsurg.2006.03.010.

  PMID: 17071205 BACKGROUND

• 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. doi: 10.1007/s002680010160.

  PMID: 10865043 BACKGROUND

• 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. doi: 10.1007/s002689900459.

  PMID: 9606288 BACKGROUND

• 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.

  PMID: 28418509 BACKGROUND

• Iglesias P, Diez 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.

  PMID: 28444664 BACKGROUND

• 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.

  PMID: 28444542 BACKGROUND

• Falk SA, Birken EA, Baran DT. Temporary postthyroidectomy hypocalcemia. Arch Otolaryngol Head Neck Surg. 1988 Feb;114(2):168-74. doi: 10.1001/archotol.1988.01860140066023.

  PMID: 3337775 BACKGROUND

• Donahue C, Pantel HJ, Yarlagadda BB, Brams D. Does Preoperative Calcium and Calcitriol Decrease Rates of Post-Thyroidectomy Hypocalcemia? A Randomized Clinical Trial. J Am Coll Surg. 2021 Jun;232(6):848-854. doi: 10.1016/j.jamcollsurg.2021.01.016. Epub 2021 Feb 23.

  PMID: 33631337 DERIVED

MeSH Terms

Conditions

Hypocalcemia; Thyroid Diseases

Interventions

Calcium Carbonate; Calcitriol

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• David Brams, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be enrolled in the study during their pre-operative consultation with the surgeon once they have been cleared to undergo total thyroidectomy per the usual screening process. The attending surgeon or an IRB approved co investigator will perform the informed consent process (see designated co-investigators). This process will occur in the General Surgery clinic when potential subjects have their 30 minute scheduled preoperative appointment prior to going to the operating room. This process will be conducted in the same manner as the informed consent process for the operation. The nature of their condition will be discussed; the potential risks and benefits of the study will be explained to subjects. The options including not enrolling, enrolling now, and the option to withdraw from the study at any time for any reason will be explained to subjects as well. Once they have consented a consent form will be signed and the subject provided a copy.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: August 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)