Trial Outcomes & Findings for Thiamine as an Adjunctive Therapy in Cardiac Surgery (NCT NCT02322892)

NCT ID: NCT02322892

Last Updated: 2017-03-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: Post-surgery within 1 hour of arrival to the ICU
• Results posted on: 2017-03-30

Participant Flow

275 coronary artery bypass grafting patients screened between January and July 2015

206 patients not included for various reasons. 5 patients were randomized, but never received the assigned treatment and was therefore not included in the pre-specified modified intend-to-treat analysis.

Participant milestones

Measure	Control Arm 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Overall Study STARTED	35	34
Overall Study COMPLETED	33	31
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Control Arm 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Overall Study Surgery cancelled	1	2
Overall Study Met exclusion criteria	0	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Thiamine as an Adjunctive Therapy in Cardiac Surgery

Baseline characteristics by cohort

Measure	Control Arm n=33 Participants 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine n=31 Participants 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Total n=64 Participants Total of all reporting groups
Age, Continuous	73 years n=5 Participants	71 years n=7 Participants	72 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	31 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

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

Population: Modified intention to treat

Outcome measures

Measure	Control Arm n=33 Participants 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine n=31 Participants 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Lactate Levels	2 mmol/L Interval 1.7 to 2.4	2.0 mmol/L Interval 1.5 to 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Arm n=33 Participants 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine n=31 Participants 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity	28 Percent change from baseline Interval 15.0 to 84.0	15 Percent change from baseline Interval 11.0 to 37.0

SECONDARY outcome

Timeframe: Until hospital discharge, limit 60 days

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

Outcome measures

Measure	Control Arm n=33 Participants 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine n=31 Participants 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Patients With Post-operative Complications	16 participants	16 participants

SECONDARY outcome

Timeframe: Until hospital discharge, limit 60 days

Duration of intensive care unit stay

Outcome measures

Measure	Control Arm n=33 Participants 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine n=31 Participants 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Length of Stay	2.3 days Interval 1.4 to 4.0	2.4 days Interval 1.1 to 4.2

SECONDARY outcome

Timeframe: Until hospital discharge, limit 60 days

Outcome measures

Measure	Control Arm n=33 Participants 50 mL normal saline solution Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)	Thiamine n=31 Participants 200 mg thiamine in 50 mL normal saline solution Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Mortality	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Six hours after end of surgery surgery

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Limit 60 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Limit 60 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From arrival to ICU to extubation, limit 6 hours

VO2 will be measured with a Compact Anesthesia monitor

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

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

Outcome measures

Outcome data not reported

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Thiamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lars W. Andersen

Beth Israel Deaconess Medical Center

Phone: 6173886343

Email: larswiuffandersen@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place