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

December 21, 2022 updated by: Bastian Lubis, Universitas Sumatera Utara

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Sumatera Utara
      • Medan, Sumatera Utara, Indonesia, 20155
        • Faculty of Medicine Universitas Sumatera Utara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Vitamin B1
Vitamin B1 (thiamine) 100mg every 6 hours x 3-days
Drug: Vitamin B
vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days
Other Names:
  • Thiamine
Placebo Comparator: Drug: Normal saline
Normal saline (0.9% NaCl solution) volume to match all components
Drug: Placebo
Normal saline (0.9% NaCl solution) volume to match all components
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon Level
Time Frame: On day 3 (at approximately 72 hours) after the first study drug dose
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
Time Frame: On day 3 (at approximately 72 hours) after the first study drug dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Investigators

  • Principal Investigator: Bastian Lubis, Dr, Faculty of Medicine Universitas Sumatera Utara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Estimate)

December 23, 2022

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Vitamin B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe