A Phase 4 interventional study of Vitamin B1-ratiopharm and Placebo in Heart Failure, Acidosis, Lactic and Thiamine Deficiency, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-26.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Supportive care
The objective of this study is to determine whether preoperative parenteral thiamin supplementation does prevent the intra and early postoperative increase of lactate and whether this effect is related to the extent of thiamine deficiency in patients undergoing heart surgery. In addition the prevalence of major thiamin deficiency in patient undergoing heart surgery will be determined.
Thiamine (vitamin B1) is a water-soluble vitamin and is involved in several stages of intermediate metabolism which are important for producing energy. Severe thiamin deficiency has been associated with severe lactic acidosis and clinical symptoms of life threatening heart failure.
To date, no study has evaluated thiamine levels in patients undergoing heart surgery and the prevalence of thiamine deficiency is not known. Furthermore it is unknown whether moderately reduced thiamin levels are associated with mild forms of perioperative cardiac failure necessitating prolonged inotropic support.
In this prospective double blind randomised controlled trial of the effect of a parenteral infusion of thiamin before induction of anaesthesia we will investigate the effect on perioperative lactate increase as primary outcome and extent and duration of inotropic support after cardiac surgery. In addition the pharmacokinetics of a intravenous infusion of 300 mg of thiamin on erythrocyte thiamin content and the amount of thiamine excreted in the 24 hours via the urine will be determined.
Baseline thiamin levels in erythrocytes before surgery, as well as nutrition history and body composition will be evaluated as effect modifier.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 30 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative
Drug: Vitamin B1-ratiopharm
100 ml normal saline, intravenous, preoperative
Drug: Placebo
300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
Also known as: Vitamin B1-ratiopharm®
100 ml normal saline, intravenous, preoperative
Thiamine status and lactate levels
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); quantity of vitamin B1 in urine and blood concentrations Lactate levels: lactate levels will be determined by blood gas analysis (BGA) within the routine check.
Time frame: perioperative
Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); Body composition: measuring with bioelectrical impedance analysis (BIA) Length of ICU and hospital stay;
Time frame: 2-3 weeks
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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