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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43928596" target="_blank" >RIV/00064173:_____/25:43928596 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/46747885:24530/25:00014633 RIV/00216208:11110/25:10499170 RIV/00216208:11120/25:43928596 RIV/00216208:11130/25:10499170 a 2 dalších

Výsledek na webu

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

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 (&gt; 80 nmol/l), which was associated with a significantly lower risk of complete non-healed sternotomy (p = 0.008). Conclusion: Optimal calcidiol level (&gt; 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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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 (&gt; 80 nmol/l), which was associated with a significantly lower risk of complete non-healed sternotomy (p = 0.008). Conclusion: Optimal calcidiol level (&gt; 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30218 - General and internal medicine

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

Trials

ISSN

1745-6215

e-ISSN

1745-6215

Svazek periodika

26

Číslo periodika v rámci svazku

June

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

9

Strana od-do

224

Kód UT WoS článku

001513579000001

EID výsledku v databázi Scopus

2-s2.0-105008809045