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.
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.
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 group | Role | What they receive |
|---|---|---|
| experimental group (vitamin B6) | Experimental | Not described Receives: Drug: vitamin B6 |
| control group (0.9% sodium chloride solution) | Placebo comparator | Not 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.
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
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
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
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
Renal function index
The renal function indexs before treatment were detected before the 7th day of treatment.
Measured: before of treatment
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.
- First posted23 Aug 2023
- Study start1 Nov 2021
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Huzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Ming Feng, The First People's Hospital of Huzhou
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Protective Effect and Clinical Analysis of Vitamin B6 in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT06008223
- Acronym / sponsor ID
- HHuzhou 001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The First People's Hospital of HuzhouUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Aug 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group (vitamin B6) | Experimental | Drug: vitamin B6 |
| control group (0.9% sodium chloride solution) | Placebo comparator | Drug: 0.9% sodium chloride solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| vitamin B6The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection. | Drug | experimental group (vitamin B6) |
| 0.9% sodium chloride solutionThat in control group were injected with 0.9% sodium chloride solution 6 ml intravenously. | Drug | control group (0.9% sodium chloride solution) |
Primary outcome
Inflammatory response index
Time frame: before treatment
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).
Inflammatory response index
Time frame: on the 7th day of treatment
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).
Oxidative stress response index
Time frame: before treatment
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.
Oxidative stress response index
Time frame: on the 7th day of treatment
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.
Renal function index
Time frame: before of treatment
The renal function indexs before treatment were detected before the 7th day of treatment.
Renal function index
Time frame: on the 7th day of treatment
The renal function indexs after treatment were detected on the 7th day of treatment.
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 23 Aug 2023.
- Derived from this study: PubMed 38691102Wang 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.
- 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.
1 site in 1 country: see every site and its status.
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.