Critically IllPhase 2TVO2_RCTNCT01985685
The Effect of Thiamine vs. Placebo on VO2 in Critical Illness
A Phase 2 study testing Thiamine in people with Critically Ill and Respiratory Failure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine the effect of thiamine therapy on oxygen consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before and after thiamine or placebo administration in patients admitted to the ICU and requiring mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Respiratory Failure
- What is being tested?
- Thiamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (age > 18 yrs) admitted to an ICU
- Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
- Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
- Upper central venous line in place
Who cannot join
- Unstable ventilator settings during measurement of VO2
- Temperature >100.5
- FIO2>60%
- Endotracheal cuff leak, chest tube, or other evident source of air leak
- Positive end expiratory pressure > 12cmH2O
- Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.
- Protected populations (pregnant woman, prisoners, cognitively impaired)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The objective of this study is to determine the effect of thiamine therapy on oxygen consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before and after thiamine or placebo administration in patients admitted to the ICU and requiring mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on the metabolic profile of the patients.
Read the detailed description
Extensive research has been done over the past two decades looking at the role of oxygen delivery (DO2) and oxygen utilization (VO2) in critical illness. VO2 depends on cardiac output, arterial oxygen content, and the body's ability to extract oxygen effectively from the blood. Oxygen demand rises in critical illness as the body goes into a catabolic state, and lower VO2 has been associated with higher lactate levels and with poorer outcomes. Although increasing DO2 was shown in past studies to raise VO2 in some patients, other investigators have found that many critically-ill patients failed to demonstrate a rise in VO2 in spite of achieving supranormal values of cardiac index (CI) and DO2. This group, in contrast to patients whose VO2 rose with the increase in CI and DO2, had exceedingly poor outcomes, suggesting that an inability to extract oxygen from the blood confers a poorer prognosis.
Thiamine deficiency can manifest in several ways, but the syndrome of wet beriberi, caused by thiamine deficiency, includes lactic acidosis, cardiac decompensation and vasodilatory shock, similar to sepsis and other forms of critical illness. The mechanism by which thiamine deficiency causes dysfunction rests upon the vitamin's essential role in the Krebs cycle and Pentose Phosphate Pathway. Lack of adequate thiamine results in the failure of pyruvate to enter the Krebs Cycle, thus preventing aerobic metabolism. The resulting decrease in aerobic metabolism and increase in anaerobic metabolism leads to decreased oxygen consumption by the tissues and increased lactic acid production.
Our group has found previously that upwards of 20% of critically ill patients with sepsis are thiamine deficient within 72 hours of presentation. In a dog model of septic shock, Lindenbaum et al have shown that, regardless of thiamine levels, supplementation with thiamine improved not only lactate clearance and mean arterial pressure, but increased VO2 as well. An increase in VO2 max after administration of thiamine to healthy volunteers has also been described. In our prior open-label study, we found that the administration of a single dose of 200mg of intravenous thiamine to critically ill patients led to a statistically significant increase in VO2 in those with normal or elevated cardiac output, suggesting that thiamine may increase the extraction component of VO2, even in the absence of absolute thiamine deficiency. This effect was not seen in patients with low cardiac output.
VO2 is known to rise in inflammatory states, reflecting increased energy expenditure. Prior studies have shown that VO2 will decrease with interventions such as fever control. In spite of VO2 being higher than normal in critically-ill patients, however, the end-organ damage and lactic acidosis suggest that it is not high enough to meet the metabolic demands of the critically-ill body. If we are able to increase VO2 further in critically-ill patients, we could potentially help maintain aerobic metabolism and decrease tissue hypoxia and the resulting end-organ damage. Our hypothesis is that administering thiamine intravenously to critically-ill patients who do not have abnormally low cardiac index will increase VO2.
We will use an anesthesia monitor with a gas exchange module to measure VO2 continuously over a 9 hour period. After 3 hours of baseline VO2 data are collected, baseline thiamine level, lactate, and central venous O2 saturation will be obtained. A single dose of 200mg of IV thiamine will then be given, and 6 hours of post-thiamine data will then be collected. We will screen all consenting patients for whom we do not know the cardiac index with a non-invasive cardiac index measurement using the Cheetah non-invasive cardiac output monitor (NICOM). We will not include patients with a cardiac index less than or equal to 2.4L/min/m2, due to our preliminary data showing these patients did not increase VO2 in response to thiamine. All patients enrolled will have cardiac index monitored continuously during the study by the NICOM, in order to assess whether or not there is any relationship between VO2 and cardiac index. Patients will also have blood drawn for a metabolomic panel before and after thiamine or placebo to assess whether thiamine has an effect on the metabolome.
- Conditions
- Critically Ill, Respiratory Failure
- Being tested
- Thiamine
- Keywords
- VO2, critically ill, oxygen consumption
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDrug
200 mg IV thiamine
| Study group | Role | What they receive |
|---|---|---|
| Thiamine | Experimental | 200mg intravenous thiamine in 50ml 5% dextrose, single dose Receives: Drug: Thiamine |
| Placebo | Placebo comparator | 50ml intravenous 5% dextrose, single dose Receives: Drug: Thiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 Over Time
The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.
Measured: 6 hrs
Secondary outcomes (2)
Percentage Change in Serum Lactate
Percentage change in serum lactate
Measured: 6 hrs
Change in Central Venous Oxygen Saturation
Change in central venous oxygen saturation
Measured: 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Berg, Beth Israel Deaconess Medical Center
- Investigators
- Katherine Berg, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985685
- Sponsor's protocol ID
- 2013P000240
- Acronym
- TVO2_RCT
- Status last verified
- Sep 2017
- First submitted
- 11 Nov 2013
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thiamine vs. Placebo on VO2 in Critical Illness
- ClinicalTrials.gov ID
- NCT01985685
- Acronym / sponsor ID
- TVO2_RCT / 2013P000240
- Conditions
- Critically Ill, Respiratory Failure
- Keywords
- VO2, critically ill, oxygen consumption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Posted 2 Oct 2017
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 the effect of thiamine therapy on oxygen consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before and after thiamine or placebo administration in patients admitted to the ICU and requiring mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on the metabolic profile of the patients.
Detailed description
Extensive research has been done over the past two decades looking at the role of oxygen delivery (DO2) and oxygen utilization (VO2) in critical illness. VO2 depends on cardiac output, arterial oxygen content, and the body's ability to extract oxygen effectively from the blood. Oxygen demand rises in critical illness as the body goes into a catabolic state, and lower VO2 has been associated with higher lactate levels and with poorer outcomes. Although increasing DO2 was shown in past studies to raise VO2 in some patients, other investigators have found that many critically-ill patients failed to demonstrate a rise in VO2 in spite of achieving supranormal values of cardiac index (CI) and DO2. This group, in contrast to patients whose VO2 rose with the increase in CI and DO2, had exceedingly poor outcomes, suggesting that an inability to extract oxygen from the blood confers a poorer prognosis.
Thiamine deficiency can manifest in several ways, but the syndrome of wet beriberi, caused by thiamine deficiency, includes lactic acidosis, cardiac decompensation and vasodilatory shock, similar to sepsis and other forms of critical illness. The mechanism by which thiamine deficiency causes dysfunction rests upon the vitamin's essential role in the Krebs cycle and Pentose Phosphate Pathway. Lack of adequate thiamine results in the failure of pyruvate to enter the Krebs Cycle, thus preventing aerobic metabolism. The resulting decrease in aerobic metabolism and increase in anaerobic metabolism leads to decreased oxygen consumption by the tissues and increased lactic acid production.
Our group has found previously that upwards of 20% of critically ill patients with sepsis are thiamine deficient within 72 hours of presentation. In a dog model of septic shock, Lindenbaum et al have shown that, regardless of thiamine levels, supplementation with thiamine improved not only lactate clearance and mean arterial pressure, but increased VO2 as well. An increase in VO2 max after administration of thiamine to healthy volunteers has also been described. In our prior open-label study, we found that the administration of a single dose of 200mg of intravenous thiamine to critically ill patients led to a statistically significant increase in VO2 in those with normal or elevated cardiac output, suggesting that thiamine may increase the extraction component of VO2, even in the absence of absolute thiamine deficiency. This effect was not seen in patients with low cardiac output.
VO2 is known to rise in inflammatory states, reflecting increased energy expenditure. Prior studies have shown that VO2 will decrease with interventions such as fever control. In spite of VO2 being higher than normal in critically-ill patients, however, the end-organ damage and lactic acidosis suggest that it is not high enough to meet the metabolic demands of the critically-ill body. If we are able to increase VO2 further in critically-ill patients, we could potentially help maintain aerobic metabolism and decrease tissue hypoxia and the resulting end-organ damage. Our hypothesis is that administering thiamine intravenously to critically-ill patients who do not have abnormally low cardiac index will increase VO2.
We will use an anesthesia monitor with a gas exchange module to measure VO2 continuously over a 9 hour period. After 3 hours of baseline VO2 data are collected, baseline thiamine level, lactate, and central venous O2 saturation will be obtained. A single dose of 200mg of IV thiamine will then be given, and 6 hours of post-thiamine data will then be collected. We will screen all consenting patients for whom we do not know the cardiac index with a non-invasive cardiac index measurement using the Cheetah non-invasive cardiac output monitor (NICOM). We will not include patients with a cardiac index less than or equal to 2.4L/min/m2, due to our preliminary data showing these patients did not increase VO2 in response to thiamine. All patients enrolled will have cardiac index monitored continuously during the study by the NICOM, in order to assess whether or not there is any relationship between VO2 and cardiac index. Patients will also have blood drawn for a metabolomic panel before and after thiamine or placebo to assess whether thiamine has an effect on the metabolome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiamine | Experimental | Drug: Thiamine200mg intravenous thiamine in 50ml 5% dextrose, single dose |
| Placebo | Placebo comparator | Drug: Thiamine50ml intravenous 5% dextrose, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age > 18 yrs) admitted to an ICU
- Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
- Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
- Upper central venous line in place
Key exclusion criteria (7 listed)
- Unstable ventilator settings during measurement of VO2
- Temperature >100.5
- FIO2>60%
- Endotracheal cuff leak, chest tube, or other evident source of air leak
- Positive end expiratory pressure > 12cmH2O
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 |
|---|---|---|
| Thiamine200 mg IV thiamine | Drug | Placebo, Thiamine |
Primary outcome
Change in VO2 Over Time
Time frame: 6 hrs
The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.
2 secondary outcomes
Percentage Change in Serum Lactate
Time frame: 6 hrs
Change in Central Venous Oxygen Saturation
Time frame: 6 hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Katherine Berg, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thiamine in people with Critically Ill and Respiratory Failure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 4 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 2 Oct 2017. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in VO2 Over Time (time frame: 6 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2017.