Increase in calcidiol level is associated with improved sternal bone healing after cardiac surgery with sternotomy—REINFORCE-D trial results.

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F27283933%3A_____%2F25%3AN0000035" target="_blank" >RIV/27283933:_____/25:N0000035 - isvavai.cz</a>

Result on the web

<a href="https://link.springer.com/article/10.1186/s13063-025-08786-x" target="_blank" >https://link.springer.com/article/10.1186/s13063-025-08786-x</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s13063-025-08786-x" target="_blank" >10.1186/s13063-025-08786-x</a>

Result language

angličtina

Original language name

Increase in calcidiol level is associated with improved sternal bone healing after cardiac surgery with sternotomy—REINFORCE-D trial results.

Original language description

Introduction: Heart 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. Objectives: The 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). Results: Statistics include 141 subjects. After a 6-month follow-up, CT imaging and calcidiol levels were performed. Primary objective: postoperative complications in sternotomy were not among the population under or above 80 nmol/l statistical difference (p = 0.907). Secondary objectives: monitored 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). Conclusion: Optimal 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 registration: EU Clinical Trials Register, EUDRA CT No: 2016-002606-39.

Czech name

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Czech description

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Type

J_ost - Miscellaneous article in a specialist periodical

CEP classification

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OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Trials

ISSN

—

e-ISSN

1745-6215

Volume of the periodical

26

Issue of the periodical within the volume

224

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

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UT code for WoS article

001513579000001

EID of the result in the Scopus database

2-s2.0-105008809045