Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

• ClinicalTrials.gov Identifier: NCT02974257
• Recruitment Status: Terminated
• First Posted: November 28, 2016
• Last Update Posted: August 9, 2022
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Katherine Berg, Beth Israel Deaconess Medical Center

Tracking Information

• First Submitted Date: November 23, 2016
• First Posted Date: November 28, 2016
• Last Update Posted Date: August 9, 2022
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: February 7, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2018)

lactate [ Time Frame: 2 days ]

The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups

Original Primary Outcome Measures (submitted: November 23, 2016)

change in oxygen consumption [ Time Frame: 2 days ]

We will evaluate the change in oxygen consumption over the two days of the study period, compared between groups

Current Secondary Outcome Measures (submitted: November 7, 2018)

• oxygen consumption [ Time Frame: 2 days ]
  The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups
• Pyruvate dehydrogenase [ Time Frame: 2 days ]
  The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups

Original Secondary Outcome Measures (submitted: November 23, 2016)

• lactate [ Time Frame: 2 days ]
  We will evaluate the absolute level and the change in lactate over two days, compared between groups
• Central venous oxygen saturation [ Time Frame: 2 days ]
  We will evaluate the absolute level and the change in central venous oxygen saturation over two days, compared between groups

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest
• Official Title: Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Cardiac Arrest
• Shock
• Lactic Acidosis
• Thiamin Deficiency

Intervention

• Drug: Thiamine
  Thiamine 500mg IV twice daily for 2 days
  Other Name: vitamin B1
• Other: placebo
  100mL normal saline IV every 12 hours for 2 days
  Other Name: normal saline

Study Arms

• Experimental: Thiamine
  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.
  Intervention: Drug: Thiamine
• Placebo Comparator: Placebo
  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.
  Intervention: Other: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 5, 2022): 36
• Original Estimated Enrollment (submitted: November 23, 2016): 100
• Actual Study Completion Date: August 1, 2022
• Actual Primary Completion Date: February 7, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02974257
• Other Study ID Numbers: 2016P000347; 1K23HL128814-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Katherine Berg, Beth Israel Deaconess Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Beth Israel Deaconess Medical Center
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Katherine M Berg, MD; Beth

• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: August 2022