Sepsis and Septic ShockNCT07786350
Thiamine, Ascorbic Acid, and Their Combination on MMP-9/TIMP-1 and Inflammatory Balance in Sepsis
A study testing Thiamine, Ascorbic Acid Injectable Product and Normal Saline 0.9% Injectable Solution in people with Sepsis and Septic Shock, run by Universitas Sumatera Utara at 2 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis and Septic Shock
- What is being tested?
- Thiamine, Ascorbic Acid Injectable Product and Normal Saline 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Apr 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Admitted to the intensive care unit with sepsis (Sepsis-3)
- SOFA score >= 2
- Arterial lactate >= 2 mmol/L
Who cannot join
- Known allergic reaction to thiamine or ascorbic acid
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Haji Adam Malik General Hospital
Medan, North Sumatra, 20222
Universitas Sumatera Utara
Medan, North Sumatra, 20222
About this study
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
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.
Read the 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.
- Conditions
- Sepsis and Septic Shock
- Being tested
- Thiamine, Ascorbic Acid Injectable Product, Normal Saline 0.9% Injectable Solution
- Keywords
- Matrix metalloproteinase-9, TIMP-1, Interleukin-6, Interleukin-10, Thiamine, Ascorbic acid
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDrug
Thiamine 200 mg IV, over 60 minutes every 12 hours for 3 days.
Ascorbic Acid Injectable ProductDrug
Ascorbic acid + Combination (thiamine + ascorbic acid)
Normal Saline 0.9% Injectable SolutionDrug
Control (normal saline)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Thiamine; Drug: Ascorbic Acid Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum MMP-9 concentration
Serum matrix metalloproteinase-9 (pg/mL) measured by ELISA
Measured: 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.
Measured: Baseline and 72 hours
Secondary outcomes (4)
Change in serum IL-6 and IL-10 concentrations
Serum IL-6 and IL-10 (pg/mL) measured by ELISA
Measured: Baseline and 72 hours
SOFA score
Sequential Organ Failure Assessment (SOFA) score, range 0-24; higher scores indicate more severe organ dysfunction
Measured: Baseline and 72 hours
Acute kidney injury
Serum creatinine >= 1.5 mg/dL.
Measured: Through ICU discharge, up to 28 days
In-hospital mortality
Death from any cause during the index hospitalization
Measured: Through hospital discharge, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Apr 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis and Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bastian Lubis, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786350
- Sponsor's protocol ID
- USU-SEPSIS-TAC-2020
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07786350
- Acronym / sponsor ID
- USU-SEPSIS-TAC-2020
- Conditions
- Sepsis and Septic Shock
- Keywords
- Matrix metalloproteinase-9, TIMP-1, Interleukin-6, Interleukin-10, Thiamine, Ascorbic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (normal saline) | Placebo comparator | Drug: Normal Saline 0.9% Injectable Solution0.9% sodium chloride 50 mL, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle. |
| Thiamine | Experimental | Drug: ThiamineThiamine 200 mg, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle. |
| Ascorbic acid | Experimental | Drug: Ascorbic Acid Injectable ProductAscorbic acid 50 mg/kg body weight, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle. |
| Combination (thiamine + ascorbic acid) | Experimental | Drug: Thiamine, Drug: Ascorbic Acid Injectable ProductThiamine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Admitted to the intensive care unit with sepsis (Sepsis-3)
- SOFA score >= 2
- Arterial lactate >= 2 mmol/L
Key exclusion criteria (1 listed)
- Known allergic reaction to thiamine or ascorbic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineThiamine 200 mg IV, over 60 minutes every 12 hours for 3 days. | Drug | Combination (thiamine + ascorbic acid), Thiamine |
| Ascorbic Acid Injectable ProductAscorbic acid + Combination (thiamine + ascorbic acid) | Drug | Ascorbic acid, Combination (thiamine + ascorbic acid) |
| Normal Saline 0.9% Injectable SolutionControl (normal saline) | Drug | Control (normal saline) |
Primary outcome
Change in serum MMP-9 concentration
Time frame: Baseline and 72 hours
Serum matrix metalloproteinase-9 (pg/mL) measured by ELISA
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.
4 secondary outcomes
Change in serum IL-6 and IL-10 concentrations
Time frame: Baseline and 72 hours
SOFA score
Time frame: Baseline and 72 hours
Acute kidney injury
Time frame: Through ICU discharge, up to 28 days
In-hospital mortality
Time frame: Through hospital discharge, up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiamine, Ascorbic Acid Injectable Product and Normal Saline 0.9% Injectable Solution in people with Sepsis and Septic Shock, run by Universitas Sumatera Utara at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum MMP-9 concentration (time frame: Baseline and 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.