The objective of this study is to determine the prevalence of thiamine deficiency (TD) in patients with heart surgery, to examine the association between thiamine levels and lactic acidosis and to prevent the increase of lactate by vitamin B1 supplementation.
Conditions
Interventions
Trade Name: Vitamin B1-ratiopharm
Product Name: Vitamin B1 –ratiopharm
Pharmaceutical Form: Solution for infusion
CAS Number: 67-03-8
Other descriptive name: THIAMINE HYDROCHLORIDE
Concentration unit:
Sponsors
Med. Univ. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o age 18 – 100 years o planned heart surgery o signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.Primary goals: oprevalence of vitamin B1 deficiency (thiamine status in erythrocytes, ETK - erythrocyte transketolase) ointraoperative maximum lactate elevation ;Secondary Objective: ouse of vasoactive drugs opostoperative lactate maximum olength of hospital stay (from admission to the hospital to discharge from the hospital) othe length of ICU stay ;Primary end point(s): 3.2.1Primary endpoint •Thiamine status: ofunctional parameter: the erythrocyte transketolase (a-ETK) expressed as TPP (thiamine pyrophosphate) effect will be determined photometrically [12, 13]. The primary endpoints are measurements: at the end of the operation and 24 hours postoperatively othe quantity of vitamin B1 in urine concentrations will be determined by HPLC methods with fluorescence detection [11-13]. This primary endpoint is the measurement of the urine thiamine concentration by collecting 24-hour-urine after supplementation till ICU stay. •Lactate levels: olactate levels will be determined by blood gas analysis (BGA) within the routine check. The primary endpoints are:the lactate maximum during operation and area under the curve (AUC) 24 hours postoperatively ;Timepoint(s) of evaluation of this end point: see above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Thiamine status: o there will be a baseline measurement of erythrocyte transketolase o measuring the urine thiamine concentration in the first and second day postoperatively by collecting 24-hour-urine o treatment effect: thiamine status change compared with baseline • Lactate levels: o lactate levels will be measured 16 times during surgery, six times in the first 24 hours and one time on the second day postoperatively. o minimum lactate level postoperatively • prevalence of thiamine deficiency and association with demographic characteristics (e.g. age, gender, BMI, heart failure, alcohol, drug use (diuretics), malnutrition, weight loss, heart insufficiency, intake of Vitamin B1 by using Food Frequency questionnaire (FFQ), Fragebogen zur Erfassung des Gesundheitsverhaltens (FEG), Subjective Global Assessment (SGA) etc.) • comparison of lactate levels with thiamine status by quantity (urine) and functional tests (erythrocyte transketolase) • length of hospital stay (from admission to the hospital to discharge from the hospital) • the length of ICU stay • to gather estimates for the difference in outcome parameters in the target population in order to plan a multicenter study ;Timepoint(s) of evaluation of this end point: not answered | — |
Countries
Austria
Contacts
Public ContactKarin Schindler
Med. Univ. Wien
Outcome results
None listed