Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C

NCT06749756 | Recruiting

• 1 other identifier: No. 742-1in2024ofLunShen(Yan）
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a kind of disease with high morbidity and mortality in ICU. At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C have anti-inflammatory, antioxidant and immune-regulating effects. The purpose of this study was to investigate whether vitamin B6, vitamin B12 combined with vitamin C can improve the microcirculation and organ dysfunction in patients with sepsis, and improve the survival rate of patients with sepsis. The study included 296 patients who met the inclusion criteria. After randomization, the experimental group was given intravenous vitamin B6 300mg qd in addition to the basic treatment of sepsis Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. Control group 1 was given vitamin B6 300mg qd and vitamin B12 0.5mg q6h intravenously for 4 days. Control group 2 was injected with vitamin C 50mg/kg q6h intravenously for 4 days. Control group 3: The same dose of placebo (0.9% sodium chloride solution) was administered for 4 days. After medication, sublingual microcirculation image and radial artery resistance index of snus pit were detected and recorded according to the time required by the study protocol. The duration of use of pressor drugs, ventilator days, ICU stay, 28-day mortality, capillary refill time, changes in SOFA score and APACHEII score on day 3 and day 7 compared with baseline values at randomization, daily veno-arterial carbon dioxide differential pressure (GAP) and central venous oxygen saturation were recorded. After the end of the experiment, statistical analysis of the data was carried out to further explore the test results

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (2)

• Improvement of microcirculation

  Sublingual microcirculation index (including perfusion vessel density (PVD) and total vessel density (TVD)) was measured after initiation of administration.

  At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.

• Improvement of microcirculation

  The radial artery resistance index of snus pit was measured after the start of administration.

  At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.

Secondary Outcomes (9)

• The duration of the patient's use of pressor drugs

  4 days

• Number of days on ventilator

  28 days

• ICU stay

  28 days

• 28-day mortality

  28 days

• Capillary refill time

  4 days

Study Arms (4)

Experimental group

EXPERIMENTAL

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.

Drug: vitamin B6+ Vitamin B12 +vitamin C

Control group 1

ACTIVE COMPARATOR

In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.

Drug: vitamin B6+ Vitamin B12

Control group 2

ACTIVE COMPARATOR

On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.

Drug: vitamin C

Control group 3

ACTIVE COMPARATOR

The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.

Drug: 0.9%Nacl

Interventions

vitamin B6+ Vitamin B12 +vitamin C DRUG

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.

Experimental group

vitamin B6+ Vitamin B12 DRUG

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 1

vitamin C DRUG

On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.

Control group 2

0.9%Nacl DRUG

The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.

Control group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and \< 85 years old
• Admitted to ICU
• Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points
• \. Obtain the informed consent of the subject or his family

You may not qualify if:

• Patients have absolute contraindications such as vitamin allergy
• Patients with a history of gout
• Death is expected within 24 hours
• Pregnant women
• Use hydroprednisone or other equivalent dose hormones \> 200mg/d within 24 hours
• Without the informed consent of the patient or his/her representative
• Patients with a history of scleroderma
• Patients with a history of vasculitis
• Patients with oral mucosal diseases
• Patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation

Sponsors & Collaborators

• Fan Zeng: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610031, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 34333556 RESULT

• 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.

  PMID: 31800708 RESULT

• 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.

  PMID: 38691102 RESULT

• 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.

  PMID: 11689441 RESULT

• 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.

  PMID: 36174744 RESULT

• 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.

  PMID: 21358394 RESULT

• 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.

  PMID: 33620405 RESULT

MeSH Terms

Conditions

Shock, Septic

Interventions

Ascorbic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

fan Zeng

CONTACT

17744339835; zengfan1985@126.com

qin Xu

CONTACT

13458134030; 2246062995@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 27, 2024
• Study Start: February 10, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)