Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)

NCT05663164 | Completed DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis; Thiamine Deficiency

Keywords

thiamine; sepsis; glucagon; ROS; Perioperative Stress Response

Outcome Measures

Primary Outcomes (2)

• Glucagon Level

  a hormone that your pancreas makes to help regulate your blood glucose (sugar) levels

  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

  On day 3 (at approximately 72 hours) after the first study drug dose

Study Arms (2)

Experimental: Vitamin B1

EXPERIMENTAL

Vitamin B1 (thiamine) 100mg every 6 hours x 3-days

Drug: Vitamin B

Drug: Normal saline

PLACEBO COMPARATOR

Normal saline (0.9% NaCl solution) volume to match all components

Drug: Placebo

Interventions

Vitamin B DRUG

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

Experimental: Vitamin B1

Placebo DRUG

Normal saline (0.9% NaCl solution) volume to match all components

Also known as: Normal saline

Drug: Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years who undergo surgery under general anesthesia
• ASA physical statuses 1 and 2
• Sepsis

You may not qualify if:

• Refuse to participate
• Diabetes mellitus, experience shock sepsis or lactic acidosis
• Have a history of hypersensitivity (allergy) to thiamine
• Thiamine deficiency
• Take immunomodulatory drugs, antiplatelet or anticoagulants surgery duration \> 6 hours, and thiamin regularly
• They experience massive bleeding and receive blood transfusions preoperatively, intraoperatively, or postoperatively

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

Location

Related Publications (9)

• Cusack B, Buggy DJ. Anaesthesia, analgesia, and the surgical stress response. BJA Educ. 2020 Sep;20(9):321-328. doi: 10.1016/j.bjae.2020.04.006. Epub 2020 Jul 21. No abstract available.

  PMID: 33456967 BACKGROUND

• Prete A, Yan Q, Al-Tarrah K, Akturk HK, Prokop LJ, Alahdab F, Foster MA, Lord JM, Karavitaki N, Wass JA, Murad MH, Arlt W, Bancos I. The cortisol stress response induced by surgery: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2018 Nov;89(5):554-567. doi: 10.1111/cen.13820. Epub 2018 Aug 23.

  PMID: 30047158 BACKGROUND

• Davis G, Fayfman M, Reyes-Umpierrez D, Hafeez S, Pasquel FJ, Vellanki P, Haw JS, Peng L, Jacobs S, Umpierrez GE. Stress hyperglycemia in general surgery: Why should we care? J Diabetes Complications. 2018 Mar;32(3):305-309. doi: 10.1016/j.jdiacomp.2017.11.010. Epub 2017 Nov 29.

  PMID: 29273446 BACKGROUND

• Sudhakaran S, Surani SR. Guidelines for Perioperative Management of the Diabetic Patient. Surg Res Pract. 2015;2015:284063. doi: 10.1155/2015/284063. Epub 2015 May 19.

  PMID: 26078998 BACKGROUND

• Hazell AS, Faim S, Wertheimer G, Silva VR, Marques CS. The impact of oxidative stress in thiamine deficiency: a multifactorial targeting issue. Neurochem Int. 2013 Apr;62(5):796-802. doi: 10.1016/j.neuint.2013.01.009. Epub 2013 Jan 18.

  PMID: 23333339 BACKGROUND

• Costa NA, Gut AL, de Souza Dorna M, Pimentel JA, Cozzolino SM, Azevedo PS, Fernandes AA, Zornoff LA, de Paiva SA, Minicucci MF. Corrigendum to "serum thiamine concentration and oxidative stress as predictors of mortality in patients with septic shock" [J Crit care 2014;29(2):249-52]. J Crit Care. 2016 Dec;36:311. doi: 10.1016/j.jcrc.2016.07.001. Epub 2016 Jul 10. No abstract available.

  PMID: 27810062 BACKGROUND

• Luong KV, Nguyen LT. The impact of thiamine treatment in the diabetes mellitus. J Clin Med Res. 2012 Jun;4(3):153-60. doi: 10.4021/jocmr890w. Epub 2012 May 15.

  PMID: 22719800 BACKGROUND

• Karkabounas S, Papadopoulos N, Anastasiadou C, Gubili C, Peschos D, Daskalou T, Fikioris N, Simos YV, Kontargiris E, Gianakopoulos X, Ragos V, Chatzidimitriou M. Effects of alpha-Lipoic Acid, Carnosine, and Thiamine Supplementation in Obese Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind Study. J Med Food. 2018 Dec;21(12):1197-1203. doi: 10.1089/jmf.2018.0007. Epub 2018 Oct 11.

  PMID: 30311825 BACKGROUND

• Lubis B, Lelo A, Amelia P, Prima A. The Effect of Thiamine, Ascorbic Acid, and the Combination of Them on the Levels of Matrix Metalloproteinase-9 (MMP-9) and Tissue Inhibitor of Matrix Metalloproteinase-1 (TIMP-1) in Sepsis Patients. Infect Drug Resist. 2022 Sep 30;15:5741-5751. doi: 10.2147/IDR.S378523. eCollection 2022.

  PMID: 36204393 BACKGROUND

MeSH Terms

Conditions

Sepsis; Thiamine Deficiency

Interventions

Folic Acid; Thiamine; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Pyrimidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bastian Lubis, Dr

  Faculty of Medicine Universitas Sumatera Utara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 23, 2022
• Study Start: October 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 1, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

ID (1)