Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
Started Feb 2012
Typical duration for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2015
CompletedFebruary 26, 2021
February 1, 2021
3 years
January 30, 2012
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
perioperative
Secondary Outcomes (1)
Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay
2-3 weeks
Study Arms (2)
Supplementation
EXPERIMENTAL6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative
Placebo
PLACEBO COMPARATOR100 ml normal saline, intravenous, preoperative
Interventions
300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
Eligibility Criteria
You may qualify if:
- age 18 - 100 years
- planned heart surgery
- signed informed consent
You may not qualify if:
- pregnancy and lactation
- known allergic reaction to the drugs used
- mental condition rendering the patient unable to give informed consent
- inability or contraindications to perform study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Vienna
Vienna, 1090, Austria
Related Publications (1)
Luger M, Hiesmayr M, Koppel P, Sima B, Ranz I, Weiss C, Konig J, Luger E, Kruschitz R, Ludvik B, Schindler K. Influence of intravenous thiamine supplementation on blood lactate concentration prior to cardiac surgery: A double-blinded, randomised controlled pilot study. Eur J Anaesthesiol. 2015 Aug;32(8):543-8. doi: 10.1097/EJA.0000000000000205.
PMID: 26066773RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Hiesmayr, Prof.,MD
MU Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael Hiesmayr
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 1, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 2, 2015
Last Updated
February 26, 2021
Record last verified: 2021-02