Lactic Acidosis, Septic Shock, Shock, Septic, Thiamine Deficiency
Conditions
Brief summary
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
Detailed 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.
Interventions
DRUGThiamine
DRUGPlacebos
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reversal of Shock | 7 days | Number of hours that the patient required vasopressors |
| Time to Normalization of Lactic Acidosis | 7 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Mortality | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Death occurring during the ICU stay |
| ICU Length of Stay | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Number of days that the patient remains in the ICU after admission to the ICU |
Countries
United States
Outcome results
None listed