Lactate Blood IncreasePhase 4TAACSNCT04641104
The Thiamine Administration After Cardiac Surgery Trial
A Phase 4 study testing Thiamine 500 MG in people with Lactate Blood Increase and Thiamine Deficiency, run by Sarah Saxena at 1 site in Belgium.
Trial summary
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lactate Blood Increase, Thiamine Deficiency
- What is being tested?
- Thiamine 500 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2020to 3 Oct 2022
- 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
- Adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the CHU de Charleroi between November 2020 and December 2021. Written informed consent will be obtained from each patient/ family member participating in the study.
Who cannot join
- Patients already supplemented with vitamins
- Patients with an allergy to thiamine
- Patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively
- Patients with mitochondrial disorders
- Patients with Child Pugh C cirrhosis
- Patients with a history of epilepsy with tonic-clonic movements postoperatively.
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.
We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.
Read the detailed description
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.
Thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as Wernicke's encephalopathy or Beri-Beri syndrome.
Thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. An increase in lactate levels is associated with a worse prognostic. A decrease is, on the contrary, associated with an improved prognostic, during CPR and also after cardiac arrest.
Recently, studies have shown that thiamine deficiency is underdiagnosed in ICU patients.
On top of this, extra-corporeal circulation can worsen this deficiency. This could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion Donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of ICU admission and improved mortality rates at 28 days post-ICU admission.
Therefore, the hypothesis of this study is that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.
- Conditions
- Lactate Blood Increase, Thiamine Deficiency
- Being tested
- Thiamine 500 MG, Placebo
- Medical subject headings
- Hyperlactatemia, Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiamine 500 MGDrug
Also called Thiamine
A solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% will be administered post-cardiac surgery in patients with lactate levels ≥ 2 mmol / L in the first 6 hours post-ICU admission.
PlaceboDrug
100 ml of NaCl 0.9% will be administered in the placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Thiamine | Experimental | Patients in this arm will receive a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9%. Receives: Drug: Thiamine 500 MG |
| Placebo | Placebo comparator | Patients in this arm will receive a solution of 100 ml of NaCl 0.9% alone. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate
Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.
Measured: 24 hours
Secondary outcomes (5)
Fluid balance
The influence of thiamine/placebo on the use of volume expansion during ICU stay will also be evaluated
Measured: 48 hours
Inotropes
The influence of thiamine: placebo on the use of inotropes during ICU stay will also be evaluated
Measured: 48 hours
Mechanical ventilation
The influence of thiamine/ placebo on extubation time will also be evaluated.
Measured: 48 hours
Length of ICU stay
The influence of thiamine/ placebo on ICU discharge will also be evaluated.
Measured: 5 days
Length of hospital stay
The influence of thiamine/ placebo on hospital discharge will also be evaluated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start20 Nov 2020
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lactate Blood IncreaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a monocentric randomized, controlled, double blind study in patients undergoing elective cardiac surgery with extra corporal circulation. Anesthesia management of these patients is standardised in terms of volume-controlled ventilation, fluid and inotropes management. Randomization of 100 patients for the administration, of a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% versus a solution of 100 ml of NaCl 0.9% alone in adult patients (≥ 18 years-old) with a lactate ≥ 2 mmol / L in the first 6 hours of ICU admission.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Saxena
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Charleroi
- Responsible party
- Sponsor-investigator, Sarah Saxena, Université Libre de Bruxelles
- Investigators
- MIchael Piagnerelli, MD; PHD, Principal investigator, CHU de Charleroi, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641104
- Sponsor's protocol ID
- TAACS trial
- Acronym
- TAACS
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frank RA, Leeper FJ, Luisi BF. Structure, mechanism and catalytic duality of thiamine-dependent enzymes. Cell Mol Life Sci. 2007 Apr;64(7-8):892-905. doi: 10.1007/s00018-007-6423-5.
PubMed 17429582Collie JTB, Greaves RF, Jones OAH, Lam Q, Eastwood GM, Bellomo R. Vitamin B1 in critically ill patients: needs and challenges. Clin Chem Lab Med. 2017 Oct 26;55(11):1652-1668. doi: 10.1515/cclm-2017-0054.
PubMed 28432843Flannery AH, Adkins DA, Cook AM. Unpeeling the Evidence for the Banana Bag: Evidence-Based Recommendations for the Management of Alcohol-Associated Vitamin and Electrolyte Deficiencies in the ICU. Crit Care Med. 2016 Aug;44(8):1545-52. doi: 10.1097/CCM.0000000000001659.
PubMed 27002274Nichol AD, Egi M, Pettila V, Bellomo R, French C, Hart G, Davies A, Stachowski E, Reade MC, Bailey M, Cooper DJ. Relative hyperlactatemia and hospital mortality in critically ill patients: a retrospective multi-centre study. Crit Care. 2010;14(1):R25. doi: 10.1186/cc8888. Epub 2010 Feb 24.
PubMed 20181242Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
PubMed 19325467Sterling SA, Puskarich MA, Shapiro NI, Trzeciak S, Kline JA, Summers RL, Jones AE; Emergency Medicine Shock Research Network (EMSHOCKNET). Characteristics and outcomes of patients with vasoplegic versus tissue dysoxic septic shock. Shock. 2013 Jul;40(1):11-4. doi: 10.1097/SHK.0b013e318298836d.
PubMed 23649098Casserly B, Phillips GS, Schorr C, Dellinger RP, Townsend SR, Osborn TM, Reinhart K, Selvakumar N, Levy MM. Lactate measurements in sepsis-induced tissue hypoperfusion: results from the Surviving Sepsis Campaign database. Crit Care Med. 2015 Mar;43(3):567-73. doi: 10.1097/CCM.0000000000000742.
PubMed 25479113Vellinga NAR, Boerma EC, Koopmans M, Donati A, Dubin A, Shapiro NI, Pearse RM, van der Voort PHJ, Dondorp AM, Bafi T, Fries M, Akarsu-Ayazoglu T, Pranskunas A, Hollenberg S, Balestra G, van Iterson M, Sadaka F, Minto G, Aypar U, Hurtado FJ, Martinelli G, Payen D, van Haren F, Holley A, Gomez H, Mehta RL, Rodriguez AH, Ruiz C, Canales HS, Duranteau J, Spronk PE, Jhanji S, Hubble S, Chierego M, Jung C, Martin D, Sorbara C, Bakker J, Ince C; microSOAP study group. Mildly elevated lactate levels are associated with microcirculatory flow abnormalities and increased mortality: a microSOAP post hoc analysis. Crit Care. 2017 Oct 18;21(1):255. doi: 10.1186/s13054-017-1842-7.
PubMed 29047411Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. doi: 10.1097/01.ccm.0000132904.35713.a7.
PubMed 15286537Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
PubMed 20179283Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.
PubMed 20463176Pan J, Peng M, Liao C, Hu X, Wang A, Li X. Relative efficacy and safety of early lactate clearance-guided therapy resuscitation in patients with sepsis: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14453. doi: 10.1097/MD.0000000000014453.
PubMed 30813144Donnino MW, Miller J, Goyal N, Loomba M, Sankey SS, Dolcourt B, Sherwin R, Otero R, Wira C. Effective lactate clearance is associated with improved outcome in post-cardiac arrest patients. Resuscitation. 2007 Nov;75(2):229-34. doi: 10.1016/j.resuscitation.2007.03.021. Epub 2007 Jun 20.
PubMed 17583412Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572.
PubMed 26771781Costa NA, Gut AL, de Souza Dorna M, Pimentel JA, Cozzolino SM, Azevedo PS, Fernandes AA, Zornoff LA, de Paiva SA, Minicucci MF. Serum thiamine concentration and oxidative stress as predictors of mortality in patients with septic shock. J Crit Care. 2014 Apr;29(2):249-52. doi: 10.1016/j.jcrc.2013.12.004. Epub 2013 Dec 14.
PubMed 24412011
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thiamine Administration After Cardiac Surgery Trial
- ClinicalTrials.gov ID
- NCT04641104
- Acronym / sponsor ID
- TAACS / TAACS trial
- Conditions
- Lactate Blood Increase, Thiamine Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sarah SaxenaUniversity, hospital or other
- Collaborators
- CHU de Charleroi
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- 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.
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.
We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.
Detailed description
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.
Thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as Wernicke's encephalopathy or Beri-Beri syndrome.
Thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. An increase in lactate levels is associated with a worse prognostic. A decrease is, on the contrary, associated with an improved prognostic, during CPR and also after cardiac arrest.
Recently, studies have shown that thiamine deficiency is underdiagnosed in ICU patients.
On top of this, extra-corporeal circulation can worsen this deficiency. This could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion Donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of ICU admission and improved mortality rates at 28 days post-ICU admission.
Therefore, the hypothesis of this study is that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a monocentric randomized, controlled, double blind study in patients undergoing elective cardiac surgery with extra corporal circulation. Anesthesia management of these patients is standardised in terms of volume-controlled ventilation, fluid and inotropes management. Randomization of 100 patients for the administration, of a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% versus a solution of 100 ml of NaCl 0.9% alone in adult patients (≥ 18 years-old) with a lactate ≥ 2 mmol / L in the first 6 hours of ICU admission.
| Arm | Type | Receives |
|---|---|---|
| Thiamine | Experimental | Drug: Thiamine 500 MGPatients in this arm will receive a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9%. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in this arm will receive a solution of 100 ml of NaCl 0.9% alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the CHU de Charleroi between November 2020 and December 2021. Written informed consent will be obtained from each patient/ family member participating in the study.
Key exclusion criteria (7 listed)
- Patients already supplemented with vitamins
- Patients with an allergy to thiamine
- Patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively
- Patients with mitochondrial disorders
- Patients with Child Pugh C cirrhosis
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 |
|---|---|---|
| Thiamine 500 MGAlso: ThiamineA solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% will be administered post-cardiac surgery in patients with lactate levels ≥ 2 mmol / L in the first 6 hours post-ICU admission. | Drug | Thiamine |
| Placebo100 ml of NaCl 0.9% will be administered in the placebo group. | Drug | Placebo |
Primary outcome
Lactate
Time frame: 24 hours
Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.
5 secondary outcomes
Fluid balance
Time frame: 48 hours
Inotropes
Time frame: 48 hours
Mechanical ventilation
Time frame: 48 hours
Length of ICU stay
Time frame: 5 days
Length of hospital stay
Time frame: 30 days
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 17 Nov 2022.
- Results publication: PubMed 17429582Frank RA, Leeper FJ, Luisi BF. Structure, mechanism and catalytic duality of thiamine-dependent enzymes. Cell Mol Life Sci. 2007 Apr;64(7-8):892-905. doi: 10.1007/s00018-007-6423-5.
- Results publication: PubMed 28432843Collie JTB, Greaves RF, Jones OAH, Lam Q, Eastwood GM, Bellomo R. Vitamin B1 in critically ill patients: needs and challenges. Clin Chem Lab Med. 2017 Oct 26;55(11):1652-1668. doi: 10.1515/cclm-2017-0054.
- Results publication: PubMed 27002274Flannery AH, Adkins DA, Cook AM. Unpeeling the Evidence for the Banana Bag: Evidence-Based Recommendations for the Management of Alcohol-Associated Vitamin and Electrolyte Deficiencies in the ICU. Crit Care Med. 2016 Aug;44(8):1545-52. doi: 10.1097/CCM.0000000000001659.
- Results publication: PubMed 20181242Nichol AD, Egi M, Pettila V, Bellomo R, French C, Hart G, Davies A, Stachowski E, Reade MC, Bailey M, Cooper DJ. Relative hyperlactatemia and hospital mortality in critically ill patients: a retrospective multi-centre study. Crit Care. 2010;14(1):R25. doi: 10.1186/cc8888. Epub 2010 Feb 24.
- Results publication: PubMed 19325467Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
- Results publication: PubMed 23649098Sterling SA, Puskarich MA, Shapiro NI, Trzeciak S, Kline JA, Summers RL, Jones AE; Emergency Medicine Shock Research Network (EMSHOCKNET). Characteristics and outcomes of patients with vasoplegic versus tissue dysoxic septic shock. Shock. 2013 Jul;40(1):11-4. doi: 10.1097/SHK.0b013e318298836d.
- Results publication: PubMed 25479113Casserly B, Phillips GS, Schorr C, Dellinger RP, Townsend SR, Osborn TM, Reinhart K, Selvakumar N, Levy MM. Lactate measurements in sepsis-induced tissue hypoperfusion: results from the Surviving Sepsis Campaign database. Crit Care Med. 2015 Mar;43(3):567-73. doi: 10.1097/CCM.0000000000000742.
- Results publication: PubMed 29047411Vellinga NAR, Boerma EC, Koopmans M, Donati A, Dubin A, Shapiro NI, Pearse RM, van der Voort PHJ, Dondorp AM, Bafi T, Fries M, Akarsu-Ayazoglu T, Pranskunas A, Hollenberg S, Balestra G, van Iterson M, Sadaka F, Minto G, Aypar U, Hurtado FJ, Martinelli G, Payen D, van Haren F, Holley A, Gomez H, Mehta RL, Rodriguez AH, Ruiz C, Canales HS, Duranteau J, Spronk PE, Jhanji S, Hubble S, Chierego M, Jung C, Martin D, Sorbara C, Bakker J, Ince C; microSOAP study group. Mildly elevated lactate levels are associated with microcirculatory flow abnormalities and increased mortality: a microSOAP post hoc analysis. Crit Care. 2017 Oct 18;21(1):255. doi: 10.1186/s13054-017-1842-7.
- Results publication: PubMed 15286537Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. doi: 10.1097/01.ccm.0000132904.35713.a7.
- Results publication: PubMed 20179283Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
- Results publication: PubMed 20463176Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.
- Results publication: PubMed 30813144Pan J, Peng M, Liao C, Hu X, Wang A, Li X. Relative efficacy and safety of early lactate clearance-guided therapy resuscitation in patients with sepsis: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14453. doi: 10.1097/MD.0000000000014453.
- Individual participant dataSharing planned: No
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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 Piagnerelli, MD; PHD principal investigator
CHU de Charleroi, Belgium
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 Thiamine 500 MG in people with Lactate Blood Increase and Thiamine Deficiency, run by Sarah Saxena at 1 site in Belgium.
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 1 inclusion and 7 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 17 Nov 2022. 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 Belgium. 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?
Lactate (time frame: 24 hours). 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 NCT04641104, which also lists 16 linked publications.
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 17 Nov 2022.