Thiamine Supplementation in Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03122678
• Other study ID #: FLA 16-058
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 5, 2016
• Est. completion date: March 14, 2019

Study information

• Verified date: March 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Thiamine

• Placebos

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

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