An interventional study of Thiamine and Ascorbic Acid Injectable Product in Sepsis and Septic Shock, sponsored by Universitas Sumatera Utara. Completed at 2 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Universitas Sumatera Utara · Not applicable, Interventional, and Treatment
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.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 40 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Universitas Sumatera Utara is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
* Known allergic reaction to thiamine or ascorbic acid
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 200 mg, infused over 60 minutes every 12 hours for 3 days, plus standard hour-1 sepsis bundle.
Drug: Thiamine
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
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: Thiamine · Drug: Ascorbic Acid Injectable Product
Thiamine 200 mg IV, over 60 minutes every 12 hours for 3 days.
Ascorbic acid + Combination (thiamine + ascorbic acid)
Control (normal saline)
Change in serum MMP-9 concentration
Serum matrix metalloproteinase-9 (pg/mL) measured by ELISA
Time frame: 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.
Time frame: Baseline and 72 hours
Change in serum IL-6 and IL-10 concentrations
Serum IL-6 and IL-10 (pg/mL) measured by ELISA
Time frame: Baseline and 72 hours
SOFA score
Sequential Organ Failure Assessment (SOFA) score, range 0-24; higher scores indicate more severe organ dysfunction
Time frame: Baseline and 72 hours
Acute kidney injury
Serum creatinine \>= 1.5 mg/dL.
Time frame: Through ICU discharge, up to 28 days
In-hospital mortality
Death from any cause during the index hospitalization
Time frame: Through hospital discharge, up to 28 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in May 2021, 13 months.
Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 13 months is below that.
Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Thiamine · Ascorbic Acid
Universitas Sumatera Utara