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NCT Number: NCT07786350

Thiamine, Ascorbic Acid, and Their Combination on MMP-9/TIMP-1 and Inflammatory Balance in Sepsis

This two-center, open-label randomized controlled trial evaluated the effect of adjunctive thiamine, ascorbic acid, and their combination compared with 0.9% saline on the extracellular matrix-remodeling axis (matrix metalloproteinase-9 [MMP-9] and tissue inhibitor of metalloproteinase-1 [TIMP-1]) and the inflammatory-balance axis (interleukin-6 [IL-6] and interleukin-10 [IL-10]) in adult patients with sepsis. Serum biomarkers were measured by ELISA at baseline and after 72 hours and related to organ dysfunction (SOFA score), acute kidney injury, and in-hospital mortality.

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Key information

Conditions

Sepsis and Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haji Adam Malik General Hospital, Medan, North Sumatra, Indonesia

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About this study

Forty adults admitted to the intensive care unit with sepsis (SOFA score >= 2 and arterial lactate >= 2 mmol/L) were randomized using a computer-generated sequence to four parallel arms: control (0.9% saline), thiamine 200 mg, ascorbic acid 50 mg/kg body weight, or the thiamine plus ascorbic acid combination. Study drugs were infused over 60 minutes every 12 hours for three days, in addition to the standard hour-1 sepsis bundle. MMP-9, TIMP-1, IL-6, and IL-10 were quantified by ELISA at baseline and 72 hours. Outcomes included the MMP-9/TIMP-1 ratio, the IL-6/IL-10 balance, SOFA score, acute kidney injury, and in-hospital mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Admitted to the intensive care unit with sepsis (Sepsis-3)
  • SOFA score >= 2
  • Arterial lactate >= 2 mmol/L

Exclusion criteria

  • Known allergic reaction to thiamine or ascorbic acid

Treatment and study plan

Thiamine

Drug

Thiamine 200 mg IV, over 60 minutes every 12 hours for 3 days.

Ascorbic Acid Injectable Product

Drug

Ascorbic acid + Combination (thiamine + ascorbic acid)

Normal Saline 0.9% Injectable Solution

Drug

Control (normal saline)

Primary outcomes

  1. Change in serum MMP-9 concentration

    Time frame: Baseline and 72 hours

    Serum matrix metalloproteinase-9 (pg/mL) measured by ELISA

  2. Change in serum TIMP-1 and MMP-9/TIMP-1 ratio

    Time frame: Baseline and 72 hours

    Serum TIMP-1 (pg/mL) and the MMP-9/TIMP-1 ratio by ELISA.

Secondary outcomes

  1. Change in serum IL-6 and IL-10 concentrations

    Time frame: Baseline and 72 hours

    Serum IL-6 and IL-10 (pg/mL) measured by ELISA

  2. SOFA score

    Time frame: Baseline and 72 hours

    Sequential Organ Failure Assessment (SOFA) score, range 0-24; higher scores indicate more severe organ dysfunction

  3. Acute kidney injury

    Time frame: Through ICU discharge, up to 28 days

    Serum creatinine >= 1.5 mg/dL.

  4. In-hospital mortality

    Time frame: Through hospital discharge, up to 28 days

    Death from any cause during the index hospitalization

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Official study title

The Effect of Thiamine, Ascorbic Acid, and Their Combination on Matrix Metalloproteinase-9 (MMP-9), Tissue Inhibitor of Metalloproteinase-1 (TIMP-1), and Inflammatory Balance (IL-6/IL-10) in Adult Sepsis Patients: A Two-Center Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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