An interventional study of Vitamin B and Placebo in Sepsis and Thiamine Deficiency, sponsored by Universitas Sumatera Utara. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Universitas Sumatera Utara · Not applicable, Interventional, and Treatment
This research is a clinical trial with a Randomized Controlled Trial (RCT) design. The purpose is to identify the effect of intravenous thiamine administration compared to normal saline placebo on glucagon levels and ROS levels in patients undergoing general anesthesia surgery
Surgery may increase postoperative cortisol and blood glucose levels. Changes in normal metabolic patterns due to surgery stimulate gluconeogenesis, glycogenolysis, proteolysis, lipolysis, and cytogenesis. These result in hyperglycemia and ketosis conditions. Surgery and anesthesia lead to an immunosuppressive effect. Increased secretion of proinflammatory cytokines may also occur after the surgery.
Besides an increase in cortisol levels, surgery can also increase cytokine response and ROS production in patients who have undergone surgery under general anesthesia after 72 hours. ROS production can also be a useful indicator in assessing the severity of surgical trauma.
In surgical procedures, there is an acute increase in reactive oxidative stress (ROS). This occurs when ischemia is followed by reperfusion. ROS can trigger tissue injury seen in transplantation (liver and heart), the release of aortic clamps during abdominal and thoracic aortic surgery, the release of limb tourniquets during orthopedic surgery, and reperfusion during and after cardiopulmonary bypass. There is a thiamine deficiency in 20% of patients treated in the intensive care unit (ICU). Thiamine deficiency is a source of lactic acidosis that does not seem in severe sepsis and septic shock. An imbalance between the formation and removal of free radicals causes a pathological condition called oxidative stress. However, the human body uses antioxidants to suppress these free radicals. One of the antioxidants that can reduce oxidative stress is thiamine. Previous studies proved this finding. Thiamine has also been able to significantly prevent the expression of inflammatory cytokines and chemokines, depending on NF-B induced by thromboxane and PGI2 synthase.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 30 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Universitas Sumatera Utara is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin B1 (thiamine) 100mg every 6 hours x 3-days
Drug: Vitamin B
Normal saline (0.9% NaCl solution) volume to match all components
Drug: Placebo
vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days
Also known as: Thiamine
Normal saline (0.9% NaCl solution) volume to match all components
Also known as: Normal saline
Glucagon Level
a hormone that your pancreas makes to help regulate your blood glucose (sugar) levels
Time frame: On day 3 (at approximately 72 hours) after the first study drug dose
ROS Level
Reactive species is the common term for both free radicals and reactive oxygen species (ROS), which include radicals, such as superoxide radical anion and hydroxyl radical, and nonradicals, such as hydrogen peroxide
Time frame: On day 3 (at approximately 72 hours) after the first study drug dose
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin B Complex
Universitas Sumatera Utara