Thiamine Supplementation in Patients With Septic Shock

NeuroTherapia, Inc.

Status and phase

Withdrawn

Phase 1

Conditions

Thiamine Deficiency

Shock, Septic

Lactic Acidosis

Septic Shock

Treatments

Drug: Thiamine

Drug: Placebos

Study type

Interventional

Funder types

Other

Identifiers

NCT03122678

FLA 16-058

Details and patient eligibility

About

To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.

Full description

Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio. Randomization will be done by the hospital pharmacy department whom will be the only unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in the patients room in the intensive care unit by the patient's assigned nurse. Blood will be collected on admission to the hospital in order to determine baseline lactate level and study eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse taking care of the patient at the time of enrollment will draw the blood sample. Standard procedure for measuring thiamine levels will be maintained including protecting the blood sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will be measured daily for 7 days or until discharge from the intensive care unit. The serial measurement of serum lactate is considered standard of care in patients with sepsis.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age>18
Sepsis (defined as presence of two or more SIRS criteria with documented or suspected infection)
SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or <4000.
Lactate >3mmol/L at the time of consent and randomization
Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus
Vasopressor dependence (defined as the continuous infusion of norepinephrine, dopamine, phenylephrine, vasopressin or epinephrine.)

Exclusion criteria

Known cirrhosis or chronic liver disease
Current thiamine supplementation
Clinical indication for thiamine (e.g. Alcohol abuse)
Comfort measures only designation
Inability to provide consent
Other causes for lactate elevation (seizure, use of medications that can cause lactic acidosis such as metformin, linezolid and anti-retrovirals, carbon monoxide, known or suspected bowel or limb ischemia, cardiac arrest prior to enrollment)