NCT03122678

Thiamine Supplementation in Patients With Septic Shock

Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Shock, Septic
• Lactic Acidosis
• Thiamine Deficiency

Interventions

Type	Name	Description
DRUG	Thiamine
DRUG	Placebos

Timeline

• Start date: 2016-11-05
• Primary completion: 2019-03-14
• Completion: 2019-03-14
• First posted: 2017-04-21
• Last updated: 2019-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study