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SepsisNCT06008223

Clinical Analysis of Vitamin B6 in Sepsis

A study testing vitamin B6 and 0.9% sodium chloride solution in people with Sepsis and Vitamin B6, run by The First People's Hospital of Huzhou at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Methodology Patients A total of 128 patients with sepsis and AKI who were admitted to several centers including Huzhou first people's Hospital combined with Wuxing People's Hospital, Linghu people's Hospital and Nanxun people's Hospital from November 1, 2021 to October 31, 2022 were included in the study. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Sepsis, Vitamin B6, Kidney Injury
What is being tested?
vitamin B6 and 0.9% sodium chloride solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteChina
Study dates
1 Nov 2021to 30 Nov 2022
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years old;
  • The hospital survival time was more than 48 hours, and the medical records were complete;
  • There is no history of vitamin B6 use in the recent period of admission (within 2 weeks before admission).

Who cannot join

  • Patients with chronic renal insufficiency or renal failure in the past;
  • Related renal injury caused by reasons other than sepsis;
  • At the time of admission to ICU, there was cardiac failure or cardiogenic shock in combination with sepsis;
  • Patients who use nephrotoxic drugs or contrast agents;
  • Previous kidney transplantation;
  • Patients with restrictive use of positive inotropic drugs (such as left ventricular outflow tract stenosis);
  • Age<18 or>65;
  • pregnant woman.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Wen-Ming Feng

    Huzhou, Zhejiang, 313000

Other trials in China

About this study

Official title: Renal Protective Effect and Clinical Analysis of Vitamin B6 in Patients With Sepsis

Methodology Patients A total of 128 patients with sepsis and AKI who were admitted to several centers including Huzhou first people's Hospital combined with Wuxing People's Hospital, Linghu people's Hospital and Nanxun people's Hospital from November 1, 2021 to October 31, 2022 were included in the study. And all patients were diagnosed by clinical examination, Diagnostic criteria sepsis was diagnosed according to the international Sepsis-3 for patients with suspected infection using the quickly Sepsis related organ failure assessment (qSOFA). The qSOFA score consists of only three criteria: Glasgow Coma Scale (GCS) <15, systolic blood pressure ≤ 100 mmHg, and respiratory rate ≥22/min. A qSOFA score of 2 or more points indicates suspected sepsis. Criteria for AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO), by the presence of one of the following: ①Increase in SCr by ≥ 0.3mg/dl (≥26.5 μ mol/L) within 48h;② Renal impairment is known or increase in SCr by ≥50% within 7days; ③ Oliguria for ≥4 hours.

All patients were authorized by their families to sign informed consent, and the study was approved by the ethics committee of the hospital.

Read more

Inclusion criteria: ①18-65 years old; ② The hospital survival time was more than 48 hours, and the medical records were complete; ③There is no history of vitamin B6 use in the recent period of admission (within 2 weeks before admission).

Exclusion criteria: ①Patients with chronic renal insufficiency or renal failure in the past; ②Related renal injury caused by reasons other than sepsis; ③At the time of admission to ICU, there was cardiac failure or cardiogenic shock in combination with sepsis; ④Patients who use nephrotoxic drugs or contrast agents; ⑤Previous kidney transplantation; ⑥Patients with restrictive use of positive inotropic drugs (such as left ventricular outflow tract stenosis); ⑦Age<18 or>65; ⑧pregnant woman.

Treatment 128 patients were divided into experimental and control group by random number table method, 64 patients in each group. Both groups were given routine treatment of sepsis and corresponding treatment of primary disease. The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection, the course of treatment is one week or until the patient dies. That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously.

Assessment The general clinical data of the two groups were recorded, including age, sex, acute physiology and chronic health status scoring system II (APACHE II), qSOFA, and the constituent ratio of primary disease before treatment.

The inflammatory reaction indexes of the two groups were detected before and on the 7th day of treatment, including Interleukin 6 (IL-6), interleukin 8 (IL-8), tumor necrosis factor (TNF-α) and endothelin-1 (ET-1). After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA). ELISA kits for IL-6 (ab178013), IL-8 (ab214030), and TNF-a(ab181241) were purchased from abcam company. ELISA kit for ET-1 (K7429-100) was purchased from BioVision. All ELISA experiments were performed according to the kit instructions.

The oxidative stress response indexs of the two groups were detected before and on the 7th day of treatment, including superoxide dismutase (SOD), glutathione (GSH), malondialdehyde (MDA). The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.

The renal function indexs before and after treatment were detected before and on the 7th day of treatment, including the blood urea nitrogen (BUN) and serum creatinine (sCr) and renal resistance index (RRI). RRI was detected by ultrasound.

And the clinical data, including the rate of renal replacement therapy, ICU length of stay, total hospitalization expenses, and 28-d mortality, were recorded.

Statistical analysis All measurements were expressed as mean ± standard deviation (x ± s). And the counting datas were expressed in the form of percentage [n (%)]. The statistical SPSS 23.0 software were performed using the two samples t-test and adjusted chi-square test for the two groups. P-value,0.05 was considered to be statistically significant.

Being tested
vitamin B6, 0.9% sodium chloride solution
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin B6Drug

    The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection.

  • 0.9% sodium chloride solutionDrug

    That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously.

Study groups in NCT06008223
Study groupRoleWhat they receive
experimental group (vitamin B6)ExperimentalNot described
Receives: Drug: vitamin B6
control group (0.9% sodium chloride solution)Placebo comparatorNot described
Receives: Drug: 0.9% sodium chloride solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory response index

    The inflammatory reaction indexes of the two groups were detected . After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA).

    Measured: before treatment

  2. Inflammatory response index

    The inflammatory reaction indexes of the two groups were detected . After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA).

    Measured: on the 7th day of treatment

  3. Oxidative stress response index

    The oxidative stress response indexs of the two groups were detected. The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.

    Measured: before treatment

  4. Oxidative stress response index

    The oxidative stress response indexs of the two groups were detected. The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA.

    Measured: on the 7th day of treatment

  5. Renal function index

    The renal function indexs before treatment were detected before the 7th day of treatment.

    Measured: before of treatment

  6. Renal function index

    The renal function indexs after treatment were detected on the 7th day of treatment.

    Measured: on the 7th day of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start1 Nov 2021
  3. Primary completion31 Oct 2022
  4. Study completion30 Nov 2022

Resources

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
Single blind
Who is masked
Participant
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008223
Sponsor's protocol ID
HHuzhou 001
Status last verified
Aug 2023
First submitted
14 Jun 2023
Last updated
23 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38691102

Questions about this trial

What is this clinical trial studying?

A study testing vitamin B6 and 0.9% sodium chloride solution in people with Sepsis and Vitamin B6, run by The First People's Hospital of Huzhou at 1 site in China.

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 3 inclusion and 8 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Inflammatory response index (time frame: before treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008223, which also lists 1 linked publication.

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 23 Aug 2023.

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