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COMPLETED
NCT07786350
NA

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

Sponsor: Universitas Sumatera Utara

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-04-01

Completion Date

2021-05-01

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

DRUG

Thiamine

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

DRUG

Ascorbic Acid Injectable Product

Ascorbic acid + Combination (thiamine + ascorbic acid)

DRUG

Normal Saline 0.9% Injectable Solution

Control (normal saline)

Locations (2)

Haji Adam Malik General Hospital

Medan, North Sumatra, Indonesia

Universitas Sumatera Utara

Medan, North Sumatra, Indonesia