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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07786350

Enrollment

Registered

2026-08-26

Start date

2020-04-01

Completion date

2021-05-01

Last updated

2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis and Septic Shock

Keywords

Matrix metalloproteinase-9, TIMP-1, Interleukin-6, Interleukin-10, Thiamine, Ascorbic acid

Brief summary

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.

Detailed description

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.

Interventions

DRUGThiamine

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

DRUGAscorbic Acid Injectable Product

Ascorbic acid + Combination (thiamine + ascorbic acid)

DRUGNormal Saline 0.9% Injectable Solution

Control (normal saline)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in serum MMP-9 concentration	Baseline and 72 hours	Serum matrix metalloproteinase-9 (pg/mL) measured by ELISA
Change in serum TIMP-1 and MMP-9/TIMP-1 ratio	Baseline and 72 hours	Serum TIMP-1 (pg/mL) and the MMP-9/TIMP-1 ratio by ELISA.

Secondary

Measure	Time frame	Description
Change in serum IL-6 and IL-10 concentrations	Baseline and 72 hours	Serum IL-6 and IL-10 (pg/mL) measured by ELISA
SOFA score	Baseline and 72 hours	Sequential Organ Failure Assessment (SOFA) score, range 0-24; higher scores indicate more severe organ dysfunction
Acute kidney injury	Through ICU discharge, up to 28 days	Serum creatinine \>= 1.5 mg/dL.
In-hospital mortality	Through hospital discharge, up to 28 days	Death from any cause during the index hospitalization

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026