Tags

Type your tag names separated by a space and hit enter

SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients.
Trials. 2014 Aug 28; 15:339.T

Abstract

BACKGROUND

Cardiac surgery has been shown to result in a significant decrease of the antioxidant selenium, which is associated with the development of multiorgan dysfunction and increased mortality. Thus, a large-scale study is needed to investigate the effect of perioperative selenium supplementation on the occurrence of postoperative organ dysfunction.

METHODS/DESIGN

We plan a prospective, randomized double-blind, multicenter controlled trial, which will be conducted in North and South America and in Europe. In this trial we will include 1,400 high-risk patients, who are most likely to benefit from selenium supplementation. This includes patients scheduled for non-emergent combined and/or complex procedures, or with a predicted operative mortality of ≥ 5% according to the EuroSCORE II. Eligible patients will be randomly assigned to either the treatment group (bolus infusion of 2,000 μg sodium selenite immediately prior to surgery, followed by an additional dosage of 2,000 μg at ICU admission, and a further daily supplementation of 1,000 μg up to 10 days or ICU discharge) or to the control group (placebo administration at the same time points).The primary endpoint of this study is a composite of 'persistent organ dysfunction' (POD) and/or death within 30 days from surgery (POD + death). POD is defined as any need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or new intermittent hemodialysis) at any time within 30 days from surgery.

DISCUSSION

The SUSTAIN-CSX™ study is a multicenter trial to investigate the effect of a perioperative high dosage sodium selenite supplementation in high-risk cardiac surgical patients.

TRIAL REGISTRATION

This trial was registered at Clinicaltrials.gov (identifier: NCT02002247) on 28 November 2013.

Authors+Show Affiliations

Department of Anesthesiology, University Hospital of the RWTH Aachen, Pauwelsstraβe 30, 52074 Aachen, Germany. christian.stoppe@gmail.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25169040

Citation

Stoppe, Christian, et al. "SodiUm SeleniTe Adminstration in Cardiac Surgery (SUSTAIN CSX-trial): Study Design of an International Multicenter Randomized Double-blinded Controlled Trial of High Dose Sodium-selenite Administration in High-risk Cardiac Surgical Patients." Trials, vol. 15, 2014, p. 339.
Stoppe C, McDonald B, Rex S, et al. SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. Trials. 2014;15:339.
Stoppe, C., McDonald, B., Rex, S., Manzanares, W., Whitlock, R., Fremes, S., Fowler, R., Lamarche, Y., Meybohm, P., Haberthür, C., Rossaint, R., Goetzenich, A., Elke, G., Day, A., & Heyland, D. K. (2014). SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. Trials, 15, 339. https://doi.org/10.1186/1745-6215-15-339
Stoppe C, et al. SodiUm SeleniTe Adminstration in Cardiac Surgery (SUSTAIN CSX-trial): Study Design of an International Multicenter Randomized Double-blinded Controlled Trial of High Dose Sodium-selenite Administration in High-risk Cardiac Surgical Patients. Trials. 2014 Aug 28;15:339. PubMed PMID: 25169040.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. AU - Stoppe,Christian, AU - McDonald,Bernard, AU - Rex,Steffen, AU - Manzanares,William, AU - Whitlock,Richard, AU - Fremes,Stephen, AU - Fowler,Robert, AU - Lamarche,Yoan, AU - Meybohm,Patrick, AU - Haberthür,Christoph, AU - Rossaint,Rolf, AU - Goetzenich,Andreas, AU - Elke,Gunnar, AU - Day,Andrew, AU - Heyland,Daren K, Y1 - 2014/08/28/ PY - 2014/06/05/received PY - 2014/08/12/accepted PY - 2014/8/30/entrez PY - 2014/8/30/pubmed PY - 2015/5/29/medline SP - 339 EP - 339 JF - Trials JO - Trials VL - 15 N2 - BACKGROUND: Cardiac surgery has been shown to result in a significant decrease of the antioxidant selenium, which is associated with the development of multiorgan dysfunction and increased mortality. Thus, a large-scale study is needed to investigate the effect of perioperative selenium supplementation on the occurrence of postoperative organ dysfunction. METHODS/DESIGN: We plan a prospective, randomized double-blind, multicenter controlled trial, which will be conducted in North and South America and in Europe. In this trial we will include 1,400 high-risk patients, who are most likely to benefit from selenium supplementation. This includes patients scheduled for non-emergent combined and/or complex procedures, or with a predicted operative mortality of ≥ 5% according to the EuroSCORE II. Eligible patients will be randomly assigned to either the treatment group (bolus infusion of 2,000 μg sodium selenite immediately prior to surgery, followed by an additional dosage of 2,000 μg at ICU admission, and a further daily supplementation of 1,000 μg up to 10 days or ICU discharge) or to the control group (placebo administration at the same time points).The primary endpoint of this study is a composite of 'persistent organ dysfunction' (POD) and/or death within 30 days from surgery (POD + death). POD is defined as any need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or new intermittent hemodialysis) at any time within 30 days from surgery. DISCUSSION: The SUSTAIN-CSX™ study is a multicenter trial to investigate the effect of a perioperative high dosage sodium selenite supplementation in high-risk cardiac surgical patients. TRIAL REGISTRATION: This trial was registered at Clinicaltrials.gov (identifier: NCT02002247) on 28 November 2013. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25169040/SodiUm_SeleniTe_Adminstration_IN_Cardiac_Surgery__SUSTAIN_CSX_trial_:_study_design_of_an_international_multicenter_randomized_double_blinded_controlled_trial_of_high_dose_sodium_selenite_administration_in_high_risk_cardiac_surgical_patients_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-339 DB - PRIME DP - Unbound Medicine ER -