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

July 8, 2019 updated by: Lahey Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • partial thyroidectomy, lobectomy, or concurrent parathyroidectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm: No pre-op medications
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
Experimental: Intervention arm: Tums and Calcitriol pre-op
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
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.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Hypocalcemia
Time Frame: 3 days post operative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical hypocalcemia
Time Frame: 3 days post operative
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
Length of stay
Time Frame: 3 days post operative
hospital length of stay
3 days post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Investigators

  • Principal Investigator: David Brams, MD, Lahey Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be managed by Co-investigators on a secure spread sheet in a password protected folder on the Lahey General Surgery shared drive. Subjects will be assigned a number and there will be no identifying information on this spreadsheet.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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