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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT05663164 (opens ClinicalTrials.gov in a new tab)Other idInterventional
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
30 participants (actual)
Sponsor
Universitas Sumatera Utara · Other
Design
Randomized · Triple masking
Countries
1 country

Indonesia

Start
1 Oct 2022
Primary completion
30 Nov 2022
Completion
1 Dec 2022
First posted
23 Dec 2022
Last update posted
23 Dec 2022
Conditions
Sepsis · Thiamine Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023
  1. N/A

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

    NCT05663164

    1 Oct 2022 to 1 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Vitamin BDrug
  • PlaceboDrug

Arms2

  • Experimental

    Experimental: Vitamin B1

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

  • Placebo comparator

    Drug: Normal saline

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Glucagon Level

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

    Registry description

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

  2. ROS Level

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

    Registry 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

7 results

Effects of α-Lipoic Acid, Carnosine, and Thiamine Supplementation in Obese Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind Study.

Karkabounas et al. 2018Journal of medicinal foodcited by 39

PMID 30311825DOI 10.1089/jmf.2018.0007PUB-30311825

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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