NCT02322892

Brief Summary

The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo. The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

December 14, 2014

Results QC Date

April 7, 2016

Last Update Submit

March 3, 2017

Conditions

Coronary Artery BypassCardiac Surgical Procedures

Keywords

ThiamineVitamin B1Coronary artery bypass graftingCardiac surgeryLactatePyruvate dehydrogenase

Outcome Measures

Primary Outcomes (1)

  • Lactate Levels

    Post-surgery within 1 hour of arrival to the ICU

Secondary Outcomes (4)

  • Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity

    Post-surgery within 1 hour of arrival to the ICU

  • Patients With Post-operative Complications

    Until hospital discharge, limit 60 days

  • Length of Stay

    Until hospital discharge, limit 60 days

  • Mortality

    Until hospital discharge, limit 60 days

Other Outcomes (6)

  • Lactate Levels

    Six hours after end of surgery surgery

  • Pyruvate Dehydrogenase (PDH) Enzyme Activity

    Six hours after end of surgery surgery

  • Time on Mechanical Ventilation

    Limit 60 days

  • +3 more other outcomes

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

50 mL normal saline solution

Drug: Normal saline solution

Thiamine

EXPERIMENTAL

200 mg thiamine in 50 mL normal saline solution

Drug: Thiamine

Interventions

ThiamineDRUG

200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)

Also known as: vitamin B1, Thiamin
Thiamine
Normal saline solutionDRUG

50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)

Control Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥ 21 years)
  • Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
  • EuroSCORE II \> 1.5%

You may not qualify if:

  • Current thiamine supplementation
  • Known allergy to thiamine
  • Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)
  • Research-protected populations (pregnant women, prisoners, the intellectually disabled)
  • Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)
  • Off-pump surgery (i.e. surgery without cardiopulmonary bypass)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Andersen LW, Holmberg MJ, Berg KM, Chase M, Cocchi MN, Sulmonte C, Balkema J, MacDonald M, Montissol S, Senthilnathan V, Liu D, Khabbaz K, Lerner A, Novack V, Liu X, Donnino MW. Thiamine as an adjunctive therapy in cardiac surgery: a randomized, double-blind, placebo-controlled, phase II trial. Crit Care. 2016 Mar 14;20:92. doi: 10.1186/s13054-016-1245-1.

    PMID: 27044557DERIVED

MeSH Terms

Interventions

ThiamineSaline Solution

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Lars W. Andersen
Organization
Beth Israel Deaconess Medical Center
larswiuffandersen@gmail.com
6173886343

Study Officials

  • Michael W Donnino, M.D.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 14, 2014

First Posted

December 23, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 30, 2017

Results First Posted

March 30, 2017

Record last verified: 2017-03

Locations

US(1)