NCT07786350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

July 14, 2026

Last Update Submit

August 23, 2026

Conditions

Sepsis and Septic Shock

Keywords

Matrix metalloproteinase-9TIMP-1Interleukin-6Interleukin-10ThiamineAscorbic acid

Outcome Measures

Primary Outcomes (2)

  • Change in serum MMP-9 concentration

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

    Baseline and 72 hours

  • Change in serum TIMP-1 and MMP-9/TIMP-1 ratio

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

    Baseline and 72 hours

Secondary Outcomes (4)

  • Change in serum IL-6 and IL-10 concentrations

    Baseline and 72 hours

  • SOFA score

    Baseline and 72 hours

  • Acute kidney injury

    Through ICU discharge, up to 28 days

  • In-hospital mortality

    Through hospital discharge, up to 28 days

Study Arms (4)

Control (normal saline)

PLACEBO COMPARATOR

0.9% sodium chloride 50 mL, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle.

Drug: Normal Saline 0.9% Injectable Solution

Thiamine

EXPERIMENTAL

Thiamine 200 mg, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle.

Drug: Thiamine

Ascorbic acid

EXPERIMENTAL

Ascorbic acid 50 mg/kg body weight, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle.

Drug: Ascorbic Acid Injectable Product

Combination (thiamine + ascorbic acid)

EXPERIMENTAL

Thiamine 200 mg plus ascorbic acid 50 mg/kg body weight, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle.

Drug: ThiamineDrug: Ascorbic Acid Injectable Product

Interventions

ThiamineDRUG

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

Combination (thiamine + ascorbic acid)Thiamine
Ascorbic Acid Injectable ProductDRUG

Ascorbic acid + Combination (thiamine + ascorbic acid)

Ascorbic acidCombination (thiamine + ascorbic acid)
Normal Saline 0.9% Injectable SolutionDRUG

Control (normal saline)

Control (normal saline)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \* Known allergic reaction to thiamine or ascorbic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haji Adam Malik General Hospital

Medan, North Sumatra, 20222, Indonesia

Location

Universitas Sumatera Utara

Medan, North Sumatra, 20222, Indonesia

Location

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

ThiamineSaline Solution

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2026

First Posted

August 26, 2026

Study Start

April 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(2)