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• Status: Withdrawn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)