Thiamine Supplementation in Patients With Septic Shock

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03122678
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Withdrawn
Phase	Phase 1
Start date	November 5, 2016
Completion date	March 14, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03649633` - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock	Phase 1/Phase 2
Terminated	`NCT04117568` - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Completed	`NCT05629780` - Temporal Changes of Lactate in CLASSIC Patients	N/A
Recruiting	`NCT04796636` - High-dose Intravenous Vitamin C in Patients With Septic Shock	Phase 1
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting	`NCT05066256` - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock	N/A
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Recruiting	`NCT02580240` - Administration of Hydrocortisone for the Treatment of Septic Shock	N/A
Recruiting	`NCT02676427` - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Recruiting	`NCT02565251` - Volemic Resuscitation in Sepsis and Septic Shock	N/A
Not yet recruiting	`NCT02547467` - TOADS Study: TO Assess Death From Septic Shock.	N/A
Completed	`NCT02638545` - Hemodynamic Effects of Dexmedetomidine in Septic Shock	Phase 3
Terminated	`NCT02335723` - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber	N/A
Completed	`NCT02079402` - Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care	Phase 4
Completed	`NCT02204852` - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients	Phase 2