Cardiac ArrestPhase 2NCT02974257

Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

A Phase 2 study testing Thiamine in people with Cardiac Arrest and Shock, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Arrest, Shock, Lactic Acidosis
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: 41 participants
Where: 1 siteUnited States
Study dates: 1 May 2017to 1 Aug 2022
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 patient (age > 18 years)
Cardiac arrest occurring while admitted to the hospital, with sustained (>20 minutes) return of spontaneous circulation (ROSC)
Mechanically ventilated at the time of enrollment
Within 12 hours of cardiac arrest event

Who cannot join

Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
Comfort measures only or anticipated withdrawal of support within 24 hours
Severe agitation
Protected populations (pregnant women, prisoners)

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.

This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate in patients who initially survive an in-hospital cardiac arrest. Patients who are successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical ventilation in the intensive care unit will be enrolled, and will get either thiamine or placebo. Their oxygen consumption and lactate will be measured at serial time points and compared between groups. The investigators' hypothesis is that thiamine will help restore the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in oxygen consumption and a decrease in lactate.

Read the detailed description

In-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption and high lactate are associated with worse outcome. Thiamine is a B vitamin necessary to maintain the body's ability to use oxygen effectively, and the investigators have found that many patients are thiamine deficient after cardiac arrest. The investigators have also found that thiamine can decrease lactate in thiamine-deficient patients who are critically ill. Patients in this study will be randomized to receive either thiamine or placebo every 12 hours for 2 days after surviving an in-hospital cardiac arrest. The investigators will measure oxygen consumption continuously during that time with a monitor attached to the ventilator tubing, and will also measure lactate and other lab values at several time points.

Conditions: Cardiac Arrest, Shock, Lactic Acidosis, Thiamin Deficiency
Being tested: Thiamine, placebo
Keywords: cardiac arrest, thiamine, oxygen consumption, lactate, shock
Medical subject headings: Heart Arrest, Shock, Acidosis, Lactic, Beriberi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ThiamineDrug
Also called vitamin B1
Thiamine 500mg IV twice daily for 2 days
placeboOther
Also called normal saline
100mL normal saline IV every 12 hours for 2 days

Study groups in NCT02974257
Study group	Role	What they receive
Thiamine	Experimental	Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points. Receives: Drug: Thiamine
Placebo	Placebo comparator	Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points. Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Lactate
The investigators will evaluate the median lactate level over two days, compared between groups
Measured: 2 days

Secondary outcomes (2)

Oxygen Consumption
The investigators will evaluate the mean oxygen consumption over two days, compared between groups
Measured: 2 days
Pyruvate Dehydrogenase
The investigators will evaluate the median pyruvate dehydrogenase levels over two days, compared between groups
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20171 Aug 2022

First posted28 Nov 2016 (estimated)
Study start1 May 2017
Primary completion7 Feb 2022
Study completion1 Aug 2022

Why it stopped: Study stopped early after consultation with DSMB

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 Cardiac ArrestStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02974257
Sponsor's protocol ID: 2016P000347
Other IDs: 1K23HL128814-01A1
Status last verified: Mar 2025
First submitted: 23 Nov 2016
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
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All Cardiac Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.
ClinicalTrials.gov ID: NCT02974257
Acronym / sponsor ID: 2016P000347
Conditions: Cardiac Arrest, Shock, Lactic Acidosis, Thiamin Deficiency
Keywords: cardiac arrest, thiamine, oxygen consumption, lactate, shock
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped early after consultation with DSMB
Enrolment: 41 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 1 May 2017 (actual)
Primary completion: 7 Feb 2022 (actual)
Study completion: 1 Aug 2022 (actual)
First posted: 28 Nov 2016 (estimated)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Thiamine	Experimental	Drug: ThiamineIntervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Placebo	Placebo comparator	Other: placeboIntervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.

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 patient (age > 18 years)
Cardiac arrest occurring while admitted to the hospital, with sustained (>20 minutes) return of spontaneous circulation (ROSC)
Mechanically ventilated at the time of enrollment
Within 12 hours of cardiac arrest event

Key exclusion criteria (4 listed)

Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
Comfort measures only or anticipated withdrawal of support within 24 hours
Severe agitation
Protected populations (pregnant women, prisoners)

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
ThiamineAlso: vitamin B1Thiamine 500mg IV twice daily for 2 days	Drug	Thiamine
placeboAlso: normal saline100mL normal saline IV every 12 hours for 2 days	Other	Placebo

Primary outcome

Lactate
Time frame: 2 days
The investigators will evaluate the median lactate level over two days, compared between groups

2 secondary outcomes

Oxygen Consumption
Time frame: 2 days
Pyruvate Dehydrogenase
Time frame: 2 days

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Thiamine	21	18
Placebo	20	18

Primary outcome: Lactate

Time frame: 2 days. Median (Inter-Quartile Range). Unit: mmol/L

Measure	Thiamine n = 17	Placebo n = 18
Value	1.9 (1.1 to 7.5)	1.8 (1.2 to 5.4)

Thiamine vs Placebo: Mean Difference (Final Values): 1.5 (95% CI -3.1 to 6.1), p = 0.9, Mixed Models Analysis

Population analysed: A total of 5 patients in the thiamine group and 4 patients in placebo group missing lactate at 48-hours due to death; these values were imputed using a 20 percent increase prior to calculating the below medians and IQRs. There was one additional patient in the thiamine group whose lactate at 48-hours was not imputed as it was missing due to non-death reasons, leading to n = 17 for thiamine (instead of 18).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to time of hospital discharge or 90 days, whichever is first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Thiamine	0 of 18 (0%)	0 of 18 (0%)	12 of 18
Placebo	0 of 18 (0%)	0 of 18 (0%)	12 of 18

Limitations and caveats (from the sponsor): The trial was placed on hold after a data safety and monitoring board (DSMB) review noted possible harm from thiamine in the subgroup of patients with a lactate \>5mmol/L at the time of study inclusion, with a similar pattern seen in a companion trial in out-of-hospital cardiac arrest (NCT03450707). While the option of continuing to enroll patients with lactate ≤ 5mmol/L was provided, the trial was terminated formally in August 2022 due to lack of feasibility.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cardiac Arrest

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock

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 M Berg, MD principal investigator

Beth

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 Cardiac Arrest and Shock, 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 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: stopped early, as of the sponsor's last update on 10 Apr 2025. 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 10 Apr 2025). 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?

Lactate (time frame: 2 days). 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 NCT02974257.

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 10 Apr 2025.