Septic Shock Clinical Trial
Official title:
Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial
Verified date | March 2019 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 14, 2019 |
Est. primary completion date | March 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Reversal of Shock | Number of hours that the patient required vasopressors | 7 days | |
Primary | Time to Normalization of Lactic Acidosis | 7 days | ||
Secondary | ICU Mortality | Death occurring during the ICU stay | 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 | |
Secondary | ICU Length of Stay | Number of days that the patient remains in the ICU after admission to the ICU | 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 |
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