Skip to main content
OpenTrials
Completed

NCT Number: NCT02322892

Thiamine as an Adjunctive Therapy in Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

Over 230,000 patients in the United States undergo Coronary Artery Bypass Grafting (CABG) each year. While mortality is relatively low, morbidity remains substantial with a significant risk of prolonged time on mechanical ventilation, prolonged length of hospital and intensive care unit stay and many other complications. CABG causes a profound stress response and significant metabolic alterations occur, including a shift from aerobic to anaerobic metabolism, causing increased levels of pyruvate and lactate. Elevated lactate, a marker of anaerobic metabolism, is a common and significant finding in patients after CABG and is correlated with increased mortality and morbidity.

Aerobic metabolism occurs when pyruvate enters the mitochondria through pyruvate decarboxylation to acetyl-Coenzyme A, facilitated by the enzyme pyruvate dehydrogenase (PDH). Decreased PDH activity may cause a shift toward anaerobic metabolism and play a role in the changes seen in patients undergoing CABG. Thiamine (vitamin B1) is a key co-factor for PDH function and will increase activity even in non-deficient states. The investigators hypothesize that thiamine administration will increase PDH activity in patients undergoing CABG, leading to increased cellular oxygen consumption, as represented by decreased lactate levels after surgery, and ultimately improved clinical outcomes.

In order to test the investigators' hypothesis and to obtain data for a large-scale clinical trial evaluating relevant clinical endpoints, the investigators are conducting a randomized, double-blind, pilot trial of thiamine in high-risk patients undergoing CABG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Thiamine

Drug

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

Other names: vitamin B1, Thiamin

Normal saline solution

Drug

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

Primary outcomes

  1. Lactate Levels

    Time frame: Post-surgery within 1 hour of arrival to the ICU

Secondary outcomes

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

    Time frame: Post-surgery within 1 hour of arrival to the ICU

    PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery.

  2. Patients With Post-operative Complications

    Time frame: Until hospital discharge, limit 60 days

    Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection

  3. Length of Stay

    Time frame: Until hospital discharge, limit 60 days

    Duration of intensive care unit stay

  4. Mortality

    Time frame: Until hospital discharge, limit 60 days

Other outcomes

  1. Lactate Levels

    Time frame: Six hours after end of surgery surgery

  2. Pyruvate Dehydrogenase (PDH) Enzyme Activity

    Time frame: Six hours after end of surgery surgery

    PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method

  3. Time on Mechanical Ventilation

    Time frame: Limit 60 days

  4. Time on Vasopressors

    Time frame: Limit 60 days

  5. Global Oxygen Consumption (VO2)

    Time frame: From arrival to ICU to extubation, limit 6 hours

    VO2 will be measured with a Compact Anesthesia monitor

  6. Cellular Oxygen Consumption

    Time frame: Post-surgery within 1 hour of arrival to the ICU

    Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • American Heart Association
  • University of Aarhus

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2014
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.