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

Primary Purpose

Sepsis, Thiamine Deficiency

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Vitamin B
Placebo
Sponsored by
Universitas Sumatera Utara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring thiamine, sepsis, glucagon, ROS, Perioperative Stress Response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18-65 years who undergo surgery under general anesthesia ASA physical statuses 1 and 2 Sepsis Exclusion Criteria: 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

Sites / Locations

  • Faculty of Medicine Universitas Sumatera Utara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Vitamin B1

Drug: Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 23, 2022
Last Updated
December 21, 2022
Sponsor
Universitas Sumatera Utara
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1. Study Identification

Unique Protocol Identification Number
NCT05663164
Brief Title
Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)
Official Title
Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS) in Perioperative Stress Response
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sumatera Utara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Thiamine Deficiency
Keywords
thiamine, sepsis, glucagon, ROS, Perioperative Stress Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Vitamin B1
Arm Type
Experimental
Arm Description
Vitamin B1 (thiamine) 100mg every 6 hours x 3-days
Arm Title
Drug: Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline (0.9% NaCl solution) volume to match all components
Intervention Type
Drug
Intervention Name(s)
Vitamin B
Other Intervention Name(s)
Thiamine
Intervention Description
vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Normal saline (0.9% NaCl solution) volume to match all components
Primary Outcome Measure Information:
Title
Glucagon Level
Description
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
Title
ROS Level
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-65 years who undergo surgery under general anesthesia ASA physical statuses 1 and 2 Sepsis Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bastian Lubis, Dr
Organizational Affiliation
Faculty of Medicine Universitas Sumatera Utara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Universitas Sumatera Utara
City
Medan
State/Province
Sumatera Utara
ZIP/Postal Code
20155
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33456967
Citation
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.
Results Reference
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PubMed Identifier
30047158
Citation
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.
Results Reference
background
PubMed Identifier
29273446
Citation
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.
Results Reference
background
PubMed Identifier
26078998
Citation
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.
Results Reference
background
PubMed Identifier
23333339
Citation
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.
Results Reference
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PubMed Identifier
27810062
Citation
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.
Results Reference
background
PubMed Identifier
22719800
Citation
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.
Results Reference
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PubMed Identifier
30311825
Citation
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.
Results Reference
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PubMed Identifier
36204393
Citation
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.
Results Reference
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Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)

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