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SepsisNCT05663164

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

A study testing Vitamin B in people with Sepsis and Thiamine Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Sepsis, Thiamine Deficiency
What is being tested?
Vitamin B
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIndonesia
Study dates
1 Oct 2022to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Faculty of Medicine Universitas Sumatera Utara

    Medan, North Sumatra, 20155

Other trials in Indonesia

About this study

Official title: Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS) in Perioperative Stress Response

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

Read the 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.

Being tested
Vitamin B, Placebo
Keywords
thiamine, sepsis, glucagon, ROS, Perioperative Stress Response
Medical subject headings
Sepsis, Thiamine Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin BDrug

    Also called Thiamine

    vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days

  • PlaceboDrug

    Also called Normal saline

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

Study groups in NCT05663164
Study groupRoleWhat they receive
Experimental: Vitamin B1ExperimentalVitamin B1 (thiamine) 100mg every 6 hours x 3-days
Receives: Drug: Vitamin B
Drug: Normal salinePlacebo comparatorNormal saline (0.9% NaCl solution) volume to match all components
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucagon Level

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

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Nov 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663164
Sponsor's protocol ID
Interventional
Status last verified
Dec 2022
First submitted
23 Nov 2022
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33456967

  • 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.

    PubMed 30047158

  • 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.

    PubMed 29273446

  • 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.

    PubMed 26078998

  • 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.

    PubMed 23333339

  • 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.

    PubMed 27810062

  • 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.

    PubMed 22719800

  • 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.

    PubMed 30311825

  • 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.

    PubMed 36204393

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin B in people with Sepsis and Thiamine Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucagon Level (time frame: On day 3 (at approximately 72 hours) after the first study drug dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663164, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.

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