Thyroid Diseases Clinical Trial
Official title:
Does Preoperative Calcium and Calcitriol Decrease Rates of Post Thyroidectomy Hypocalcemia?
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.
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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