Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study)

被引：56

作者：

Amrein, Karin ^{[1
]}

Parekh, Dhruv ^{[2
]}

Westphal, Sabine ^{[3
]}

Preiser, Jean-Charles ^{[4
]}

Berghold, Andrea ^{[5
]}

Riedl, Regina ^{[5
]}

Eller, Philipp ^{[6
,13
]}

Schellongowski, Peter ^{[7
]}

Thickett, David ^{[2
,8
]}

Meybohm, Patrick ^{[3
,9
,39
]}

Marschalek, Corinna ^{[10
]}

Schmutz, Rene ^{[10
]}

Clodi, Martin ^{[11
]}

Resl, Michael ^{[11
]}

Krasser, Mario ^{[12
]}

Michlmayr, Matthias ^{[12
]}

Reisinger, Johann ^{[12
]}

Schiller, Alexandra ^{[12
]}

Verheyen, Nicolas Dominik ^{[13
]}

von Lewinski, Dirk ^{[13
]}

Deininger, Marlene Sandra ^{[13
]}

Muench, Andreas ^{[13
]}

Simonis, Holger ^{[13
]}

Zajic, Paul ^{[13
]}

Lindenau, Ines ^{[13
]}

Holl, Alexander ^{[13
]}

Pichler, Alexander ^{[13
]}

Purkart, Tadeja Urbanic ^{[13
]}

Hoffmann, Magdalena ^{[13
]}

Ritsch, Katharina ^{[13
]}

Schmidt, Simon ^{[13
]}

Bellmann, Romuald ^{[14
]}

Brandtner, Anna ^{[14
]}

Ditlbacher, Adelheid ^{[14
]}

Hasslacher, Julia ^{[14
]}

Joannidis, Michael ^{[14
]}

Peer, Andreas ^{[14
]}

Zotter, Klemens ^{[14
]}

Biedermann, Christoph Martin ^{[15
]}

Valentin, Andreas ^{[15
]}

Wimmer, Franz ^{[15
]}

Demschar, Susanne ^{[16
]}

Koestenberger, Markus ^{[16
]}

Likar, Rudolf ^{[16
]}

Neuwersch, Stefan ^{[16
]}

Pogatschnigg, Michael ^{[16
]}

Trummer, Brigitte ^{[16
]}

Duenser, Martin ^{[17
]}

Meier, Jens ^{[17
]}

Kainz, Johann ^{[18
]}

机构：

[1] Med Univ Graz, Dept Internal Med, Graz, Austria

[2] Univ Hosp Birmingham NHS Fdn Trust, Birmingham Acute Care Res Grp, Birmingham, W Midlands, England

[3] Goethe Univ, Univ Hosp Frankfurt, Dept Anesthesiol Intens Care Med & Pain Therapy, Frankfurt, Germany

[4] Erasme Univ Hosp, Intens Care Med, Brussels, Belgium

[5] Med Univ Graz, Inst Med Informat Stat & Documentat, Graz, Austria

[6] Univ Hosp Graz, Dept Internal Med, Intens Care Unit, Graz, Austria

[7] Med Univ Wien, Univ Hosp Internal Med 1, Vienna, Austria

[8] Univ Birmingham, Sch Clin & Expt Med, Birmingham, W Midlands, England

[9] Univ Hosp Wuerzburg, Dept Anesthesiol, Wurzburg, Germany

[10] Barmherzige Brueder, Vienna, Austria

[11] Barmherzige Brueder, Linz, Austria

[12] Ordensklinikum Linz, Linz, Austria

[13] Med Univ Graz, Graz, Austria

[14] Med Univ Innsbruck, Innsbruck, Austria

[15] Kardinal Schwarzenberg Klinikum, Schwarzach, Austria

[16] Klinikum Klagenfurt Worthersee, Klagenfurt, Austria

[17] Kepler Univ Hosp, Linz, Austria

[18] LKH Leoben, Standort Bruck Mur, Austria

[19] LKH Graz II, Standort Enzenbach, Austria

[20] LKH Feldbach, Feldbach, Austria

[21] LKH Fuerstenfeld, Furstenfeld, Austria

[22] LKH Hochsteiermark, Standort Leoben, Austria

[23] Barmherzige Brueder St Veit Glan, St Veit An Der Glan, Austria

[24] LKH Villach, Villach, Austria

[25] Med Univ Vienna, Vienna, Austria

[26] Wiener Krankenanstaltverband, Vienna, Austria

[27] CHU Charleroi, Charleroi, Belgium

[28] CHU Ambroise Pare, Mons, Belgium

[29] CHR Citadelle, Liege, Belgium

[30] Erasme Univ Hosp, Brussels, Belgium

[31] Univ Hosp Frankfurt, Frankfurt, Germany

[32] Univ Hosp Schleswig Holstein, Campus Kiel, Kiel, Germany

[33] Univ Hosp Schleswig Holstein, Campus Luebeck, Kiel, Germany

[34] Univ Hosp Bonn, Bonn, Germany

[35] TUM, Klinikum Rechts Isar, Munich, Germany

[36] Muenchen Klinikum Neuperlach, Munich, Germany

[37] HGZ Bad Bevensen, Bad Bevensen, Germany

[38] Charite, Berlin, Germany

[39] Univ Hosp Wuerzburg, Wurzburg, Germany

[40] Univ Med Mainz, Mainz, Germany

[41] RWTH Aachen Univ Hosp, Aachen, Germany

[42] Univ Hosp Zurich, Zurich, Switzerland

[43] Bern Univ Hosp, Bern, Switzerland

[44] BCTU, Birmingham, W Midlands, England

[45] Queens Univ Belfast, Belfast, Antrim, North Ireland

[46] UHB, Birmingham, W Midlands, England

[47] Univ Warwick, Coventry, W Midlands, England

[48] GSTT, London, England

[49] Cardiff Univ, Cardiff, S Glam, Wales

[50] UCLH, London, England

来源：

BMJ OPEN | 2019年 / 9卷 / 11期

关键词：

25-HYDROXYVITAMIN D; CALCIUM;

D O I：

10.1136/bmjopen-2019-031083

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Observational studies have demonstrated an association between vitamin D deficiency and increased risk of morbidity and mortality in critically ill patients. Cohort studies and pilot trials have suggested promising beneficial effects of vitamin D replacement in the critical ill, at least in patients with severe vitamin D deficiency. As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients. Methods and analysis In this randomised, placebo-controlled, double-blind, multicentre, international trial, 2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D <= 12 ng/mL) will be randomised in a 1:1 ratio by www.randomizer.at to receive a loading dose of 540000 IU cholecalciferol within 72 hours after intensive care unit (ICU) admission, followed by 4000 IU daily for 90 days or placebo. Hypercalcaemia may occur as a side effect, but is monitored by regular checks of the calcium level. The primary outcome is all-cause mortality at 28 days after randomisation. Secondary outcomes are: ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA) score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life. Recruitment status is ongoing.

引用

页数：8

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