• Je něco špatně v tomto záznamu ?

Vitamin D for prevention of sternotomy healing complications: REINFORCE-D trial

M. Čečrle, D. Černý, E. Sedláčková, B. Míková, V. Dudková, E. Drncová, M. Pokusová, I. Skalský, J. Tamášová, M. Halačová

. 2020 ; 21 (1) : 1018. [pub] 20201211

Jazyk angličtina Země Velká Británie

Typ dokumentu časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc21019661

Grantová podpora
Ig 168602 Ministerstvo Zdravotnictví Ceské Republiky (CZ)
IG 168 601 Ministerstvo Zdravotnictví Ceské Republiky
SVV 260 263 Univerzita Karlova v Praze (CZ)

BACKGROUND: Most cardiac surgery patients undergo median sternotomy during open heart surgery. Sternotomy healing is an arduous, very complex, and multifactorial process dependent on many independent factors affecting the sternum and the surrounding soft tissues. Complication rates for median sternotomy range from 0.5 to 5%; however, mortality rates from complications are very variable at 7-80%. Low calcidiol concentration below 80 nmol/L results in calcium absorptive impairment and carries a risk of bone loss, which is considered as a risk factor in the sternotomy healing process. The primary objective of this clinical trial is to compare the incidence of all postoperative sternotomy healing complications in two parallel patient groups administered cholecalciferol or placebo. The secondary objectives are focused on general patient recovery process: sternal bone healing grade at the end of the trial, length of hospitalization, number of days spent in the ICU, number of days spent on mechanical lung ventilation, and number of hospital readmissions for sternotomy complications. METHODS: This clinical trial is conducted as monocentric, randomized, double-blind, placebo-controlled, with planned enrollment of 600 patients over 4 years, approximately 300 in the placebo arm and 300 in the treatment arm. Males and females from 18 to 95 years of age who fulfill the indication criteria for undergoing cardiac surgery with median sternotomy can be included in this clinical trial, if they meet the eligibility criteria. DISCUSSION: REINFORCE-D is the first monocentric trial dividing patients into groups based on serum calcidiol levels, and with dosing based on serum calcidiol levels. This trial may help to open up a wider range of postoperative healing issues. TRIAL REGISTRATION: EU Clinical Trials Register, EUDRA CT No: 2016-002606-39 . Registered on September 8, 2016.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21019661
003      
CZ-PrNML
005      
20240611144242.0
007      
ta
008      
210728s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1186/s13063-020-04920-z $2 doi
035    __
$a (PubMed)33308291
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Čečrle, Michal $u Department of Clinical Pharmacy, Na Homolce Hospital, Prague, Czech Republic $u Institute of Pharmacology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic
245    10
$a Vitamin D for prevention of sternotomy healing complications: REINFORCE-D trial / $c M. Čečrle, D. Černý, E. Sedláčková, B. Míková, V. Dudková, E. Drncová, M. Pokusová, I. Skalský, J. Tamášová, M. Halačová
520    9_
$a BACKGROUND: Most cardiac surgery patients undergo median sternotomy during open heart surgery. Sternotomy healing is an arduous, very complex, and multifactorial process dependent on many independent factors affecting the sternum and the surrounding soft tissues. Complication rates for median sternotomy range from 0.5 to 5%; however, mortality rates from complications are very variable at 7-80%. Low calcidiol concentration below 80 nmol/L results in calcium absorptive impairment and carries a risk of bone loss, which is considered as a risk factor in the sternotomy healing process. The primary objective of this clinical trial is to compare the incidence of all postoperative sternotomy healing complications in two parallel patient groups administered cholecalciferol or placebo. The secondary objectives are focused on general patient recovery process: sternal bone healing grade at the end of the trial, length of hospitalization, number of days spent in the ICU, number of days spent on mechanical lung ventilation, and number of hospital readmissions for sternotomy complications. METHODS: This clinical trial is conducted as monocentric, randomized, double-blind, placebo-controlled, with planned enrollment of 600 patients over 4 years, approximately 300 in the placebo arm and 300 in the treatment arm. Males and females from 18 to 95 years of age who fulfill the indication criteria for undergoing cardiac surgery with median sternotomy can be included in this clinical trial, if they meet the eligibility criteria. DISCUSSION: REINFORCE-D is the first monocentric trial dividing patients into groups based on serum calcidiol levels, and with dosing based on serum calcidiol levels. This trial may help to open up a wider range of postoperative healing issues. TRIAL REGISTRATION: EU Clinical Trials Register, EUDRA CT No: 2016-002606-39 . Registered on September 8, 2016.
650    12
$a kardiochirurgické výkony $x škodlivé účinky $7 D006348
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a pooperační komplikace $x etiologie $x prevence a kontrola $7 D011183
650    12
$a sternotomie $x škodlivé účinky $7 D056346
650    _2
$a vitamin D $x škodlivé účinky $7 D014807
650    _2
$a hojení ran $7 D014945
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Černý, Dalibor $u Department of Clinical Pharmacy, Na Homolce Hospital, Prague, Czech Republic. dalibor.cerny@homolka.cz $u Institute of Pharmacology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic. dalibor.cerny@homolka.cz
700    1_
$a Sedláčková, Eva $u Department of Cardiac Surgery, Na Homolce Hospital, Prague, Czech Republic
700    1_
$a Míková, Barbora $u Department of Radiology, Na Homolce Hospital, Prague, Czech Republic
700    1_
$a Dudková, Vlasta $u Department of Clinical Biochemistry, Hematology and Immunology, Na Homolce Hospital, Prague, Czech Republic
700    1_
$a Drncová, Eva $u Department of Clinical Biochemistry, Hematology and Immunology, Na Homolce Hospital, Prague, Czech Republic $7 xx0318265
700    1_
$a Pokusová, Michala $u Hospital Pharmacy, Na Homolce Hospital, Prague, Czech Republic
700    1_
$a Skalský, Ivo $u Department of Cardiac Surgery, Na Homolce Hospital, Prague, Czech Republic
700    1_
$a Tamášová, Jana $u Department of Medical Physics, Na Homolce Hospital, Prague, Czech Republic
700    1_
$a Halačová, Milada $u Department of Clinical Pharmacy, Na Homolce Hospital, Prague, Czech Republic $u Department of Pharmacology, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic $7 xx0063011
773    0_
$w MED00163187 $t Trials $x 1745-6215 $g Roč. 21, č. 1 (2020), s. 1018
856    41
$u https://pubmed.ncbi.nlm.nih.gov/33308291 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210728 $b ABA008
991    __
$a 20240611144239 $b ABA008
999    __
$a ok $b bmc $g 1690470 $s 1140107
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 21 $c 1 $d 1018 $e 20201211 $i 1745-6215 $m Trials $n Trials $x MED00163187
GRA    __
$a Ig 168602 $p Ministerstvo Zdravotnictví Ceské Republiky (CZ)
GRA    __
$a IG 168 601 $p Ministerstvo Zdravotnictví Ceské Republiky
GRA    __
$a SVV 260 263 $p Univerzita Karlova v Praze (CZ)
LZP    __
$a Pubmed-20210728

Najít záznam

Citační ukazatele

Možnosti archivace