Clinical Trial: Thiamine Supplementation in Patients With Septic Shock

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.

Detailed Summary: 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.
Sponsor: The Cleveland Clinic

Current Primary Outcome:

• Time to Reversal of Shock [ Time Frame: 7 days ]
  Number of hours that the patient required vasopressors
• Time to Normalization of Lactic Acidosis [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• ICU Mortality [ Time Frame: 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 [ Time Frame: 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

Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: February 16, 2017
Date Started: November 5, 2016
Date Completion: April 1, 2018
Last Updated: April 18, 2017
Last Verified: April 2017