Thiamine Supplementation in Patients With Septic Shock
Withdrawn before enrolling · Phase 1 · Has a placebo group
Conditions studied: Septic Shock, Shock, Septic, Lactic Acidosis, Thiamine Deficiency
In brief
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
Key facts
- Study ID
- NCT03122678
- Run by
- The Cleveland Clinic
- People needed
- 0
- Starts
- 2016-11-05
- Expected to finish
- 2019-03-14
- Last updated by the study team
- 2019-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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)
Where it is running
- Cleveland Clinic Florida — Weston, Florida, United States
Full record on ClinicalTrials.gov
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