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

NCT07786350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-26

No results posted yet for this study

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.

Conditions

  • Sepsis and Septic Shock

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)

Sponsors & Collaborators

  • Universitas Sumatera Utara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07786350 on ClinicalTrials.gov