Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
NCT ID: NCT06749756
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
296 participants
INTERVENTIONAL
2025-02-10
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental group
In addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days.
vitamin B6+ Vitamin B12 +vitamin C
In addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days.
Control group 1
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
vitamin B6+ Vitamin B12
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
Control group 2
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
vitamin C
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
Control group 3
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
0.9%Nacl
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
Interventions
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vitamin B6+ Vitamin B12 +vitamin C
In addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days.
vitamin B6+ Vitamin B12
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
vitamin C
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
0.9%Nacl
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
Eligibility Criteria
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Inclusion Criteria
2. Admitted to ICU
3. Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points
5\. Obtain the informed consent of the subject or his family
Exclusion Criteria
2. Patients with a history of gout
3. Death is expected within 24 hours
4. Pregnant women
5. Use hydroprednisone or other equivalent dose hormones \> 200mg/d within 24 hours
6. Without the informed consent of the patient or his/her representative
7. Patients with a history of scleroderma
8. Patients with a history of vasculitis
9. Patients with oral mucosal diseases
10. Patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation
18 Years
85 Years
ALL
No
Sponsors
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Fan Zeng
OTHER
Responsible Party
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Fan Zeng
Deputy chief physician
Locations
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wald EL, Badke CM, Hintz LK, Spewak M, Sanchez-Pinto LN. Vitamin therapy in sepsis. Pediatr Res. 2022 Jan;91(2):328-336. doi: 10.1038/s41390-021-01673-6. Epub 2021 Jul 31.
Giustina AD, Danielski LG, Novochadlo MM, Goldim MPS, Joaquim L, Metzker KLL, Carli RJ, Denicol T, Cidreira T, Vieira T, Petronilho F. Vitamin B6 reduces oxidative stress in lungs and liver in experimental sepsis. An Acad Bras Cienc. 2019 Dec 2;91(4):e20190434. doi: 10.1590/0001-3765201920190434. eCollection 2019.
Wang Y, Lu WL, Feng WM, Xu W, Liu LH, He LM. RENAL PROTECTIVE EFFECT AND CLINICAL ANALYSIS OF VITAMIN B 6 IN PATIENTS WITH SEPSIS. Shock. 2024 Jun 1;61(6):841-847. doi: 10.1097/SHK.0000000000002329. Epub 2024 Apr 26.
Zhao W, Zhang J, Lu Y, Wang R. The vasorelaxant effect of H(2)S as a novel endogenous gaseous K(ATP) channel opener. EMBO J. 2001 Nov 1;20(21):6008-16. doi: 10.1093/emboj/20.21.6008.
Patel JJ, Willoughby R, Peterson J, Carver T, Zelten J, Markiewicz A, Spiegelhoff K, Hipp LA, Canales B, Szabo A, Heyland DK, Stoppe C, Zielonka J, Freed JK. High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial). Chest. 2023 Feb;163(2):303-312. doi: 10.1016/j.chest.2022.09.021. Epub 2022 Sep 26.
Fisher BJ, Seropian IM, Kraskauskas D, Thakkar JN, Voelkel NF, Fowler AA 3rd, Natarajan R. Ascorbic acid attenuates lipopolysaccharide-induced acute lung injury. Crit Care Med. 2011 Jun;39(6):1454-60. doi: 10.1097/CCM.0b013e3182120cb8.
Sevransky JE, Rothman RE, Hager DN, Bernard GR, Brown SM, Buchman TG, Busse LW, Coopersmith CM, DeWilde C, Ely EW, Eyzaguirre LM, Fowler AA, Gaieski DF, Gong MN, Hall A, Hinson JS, Hooper MH, Kelen GD, Khan A, Levine MA, Lewis RJ, Lindsell CJ, Marlin JS, McGlothlin A, Moore BL, Nugent KL, Nwosu S, Polito CC, Rice TW, Ricketts EP, Rudolph CC, Sanfilippo F, Viele K, Martin GS, Wright DW; VICTAS Investigators. Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):742-750. doi: 10.1001/jama.2020.24505.
Other Identifiers
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No. 742-1in2024ofLunShen(Yan）
Identifier Type: -
Identifier Source: org_study_id
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