A Phase 1 interventional study of Thiamine and Placebos in Septic Shock, Shock, Septic and Lactic Acidosis, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by The Cleveland Clinic · Phase 1, Interventional, and Treatment
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
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Exclusion Criteria:
Patients will receive 200mg thiamine in 50mL of 5% dextrose once daily for 7 days or until discharge from the intensive care unit.
Drug: Thiamine
Patients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit.
Drug: Placebos
Also known as: Vitamin B1
Also known as: 50mL 5% dextrose
Time to Reversal of Shock
Number of hours that the patient required vasopressors
Time frame: 7 days
Time to Normalization of Lactic Acidosis
Time frame: 7 days
ICU Mortality
Death occurring during the ICU 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
ICU Length of Stay
Number of days that the patient remains in the ICU after admission to the ICU
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
Plan to share: No
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This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thiamine