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

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ClinicalTrials.gov Identifier: NCT03869398
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

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.


Condition or disease Intervention/treatment Phase
Hypocalcemia Thyroid Diseases Dietary Supplement: Tums Dietary Supplement: Calcitriol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Length of stay [ Time Frame: 3 days post operative ]
    hospital length of stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • partial thyroidectomy, lobectomy, or concurrent parathyroidectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869398


Locations
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United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: David Brams, MD Lahey Clinic

Publications:

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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT03869398     History of Changes
Other Study ID Numbers: 2017-048
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Calcitriol
Hypocalcemia
Thyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
Calcium, Dietary
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents