Overview

Thiamine Supplementation in Patients With Septic Shock

Status:
Withdrawn
Trial end date:
2019-03-14
Target enrollment:
0
Participant gender:
All
Summary
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Treatments:
Thiamine
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)