Trial reportTrials2025
Increase in calcidiol level is associated with improved sternal bone healing after cardiac surgery with sternotomy-REINFORCE-D trial results.
Trial report in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
introductionHeart surgery is associated with a sternotomy in most patients. Low serum calcidiol level below 80 nmol/l carries the risk of bone loss as a risk factor in sternotomy healing.
objectivesThe primary objective was to compare postoperative complications of sternotomy healing in two groups of patients treated with cholecalciferol or placebo. Secondary objectives were focused on the degree of sternal healing, length of hospitalization, number of days spent in ICU and mechanical ventilation, and number of repeated hospitalizations for sternotomy complications. METHODOLOGY: Monocentric, randomized, double-blind, placebo-controlled, prospective study was conducted from September 2016 to December 2020 at Na Homolce Hospital. Of the 216 originally recruited and randomized subjects, 141 completed the study. Seventy-two subjects were enrolled in the cholecalciferol arm, and sixty-nine subjects in the placebo arm. The detailed methodology has been published previously. The results are presented as a comparison between two groups: calcidiol above 80 nmol/l (saturated subjects) and the calcidiol lower or equal to 80 nmol/l (unsaturated subjects).
resultsStatistics include 141 subjects. After a 6-month follow-up, CT imaging and calcidiol levels were performed. PRIMARY
objectivepostoperative complications in sternotomy were not among the population under or above 80 nmol/l statistical difference (p = 0.907). SECONDARY
objectivesmonitored parameters did not differ between individual arms. But the key was the state of saturation with calcidiol (> 80 nmol/l), which was associated with a significantly lower risk of complete non-healed sternotomy (p = 0.008).
conclusionOptimal calcidiol level (> 80 nmol/l) indicates a positive trend towards greater sternal healing. Cholecalciferol oral administration can be considered as a safe method how to achieve the required calcidiol concentration.
trial registrationEU Clinical Trials Register, EUDRA CT No: 2016-002606-39.
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