Clinical trial NCT03122678: Thiamine Supplementation in Patients With Septic Shock
Official title: Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Septic Shock
Shock, Septic
Lactic Acidosis
Thiamine Deficiency
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to Reversal of Shock
timeFrame: 7 days
measure: Time to Normalization of Lactic Acidosis
timeFrame: 7 days
Secondary outcomes:
measure: ICU Mortality
timeFrame: 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
measure: ICU Length of Stay
timeFrame: 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
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Jinesh Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: