Heart FailurePhase 4NCT01524315
Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery
A Phase 4 study testing Vitamin B1-ratiopharm in people with Heart Failure and Acidosis, Lactic, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acidosis, Lactic, Thiamine Deficiency
- What is being tested?
- Vitamin B1-ratiopharm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2012to 2 Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 - 100 years
- planned heart surgery
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Acidosis, Lactic, Thiamine Deficiency
- Being tested
- Vitamin B1-ratiopharm, Placebo
- Keywords
- Thiamine, Vitamin B1, Thiamine Deficiency, Thiamine supplementation, Cardiac surgery, Lactic Acid
- Medical subject headings
- Heart Failure, Acidosis, Lactic, Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B1-ratiopharmDrug
Also called Vitamin B1-ratiopharm®
300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
PlaceboDrug
100 ml normal saline, intravenous, preoperative
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Experimental | 6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative Receives: Drug: Vitamin B1-ratiopharm |
| Placebo | Placebo comparator | 100 ml normal saline, intravenous, preoperative Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: perioperative
Secondary outcomes (1)
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;
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study start1 Feb 2012
- Primary completion1 Feb 2015
- Study completion2 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Hiesmayr, Medical University of Vienna
- Investigators
- Michael Hiesmayr, Prof.,MD, Principal investigator, MU Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524315
- Sponsor's protocol ID
- 2011-004080-70
- Other IDs
- 2011-004080-70
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2012
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26066773
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study
- ClinicalTrials.gov ID
- NCT01524315
- Acronym / sponsor ID
- 2011-004080-70
- Conditions
- Heart Failure, Acidosis, Lactic, Thiamine Deficiency
- Keywords
- Thiamine, Vitamin B1, Thiamine Deficiency, Thiamine supplementation, Cardiac surgery, Lactic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 2 Feb 2015 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Drug: Vitamin B1-ratiopharm6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative |
| Placebo | Placebo comparator | Drug: Placebo100 ml normal saline, intravenous, preoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 - 100 years
- planned heart surgery
- signed informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B1-ratiopharmAlso: Vitamin B1-ratiopharm®300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative | Drug | Supplementation |
| Placebo100 ml normal saline, intravenous, preoperative | Drug | Placebo |
Primary outcome
Thiamine status and lactate levels
Time frame: perioperative
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.
1 secondary outcome
Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay
Time frame: 2-3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Results publication: PubMed 26066773Luger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hiesmayr, Prof.,MD principal investigator
MU Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin B1-ratiopharm in people with Heart Failure and Acidosis, Lactic, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiamine status and lactate levels (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.