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Clinical Analysis of Vitamin B6 in Sepsis

Primary Purpose

Sepsis, Vitamin B6, Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vitamin B6
0.9% sodium chloride solution
Sponsored by
The First People's Hospital of Huzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

  • Wen-Ming Feng

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group (vitamin B6)

control group (0.9% sodium chloride solution)

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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.
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.
Renal function index
The renal function indexs before treatment were detected before the 7th day of treatment.
Renal function index
The renal function indexs after treatment were detected on the 7th day of treatment.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
August 15, 2023
Sponsor
The First People's Hospital of Huzhou
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1. Study Identification

Unique Protocol Identification Number
NCT06008223
Brief Title
Clinical Analysis of Vitamin B6 in Sepsis
Official Title
Renal Protective Effect and Clinical Analysis of Vitamin B6 in Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Huzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Vitamin B6, Kidney Injury, Inflammatory Response, Oxidative Stress Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group (vitamin B6)
Arm Type
Experimental
Arm Title
control group (0.9% sodium chloride solution)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
vitamin B6
Intervention Description
The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection.
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously.
Primary Outcome Measure Information:
Title
Inflammatory response index
Description
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).
Time Frame
before treatment
Title
Inflammatory response index
Description
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).
Time Frame
on the 7th day of treatment
Title
Oxidative stress response index
Description
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.
Time Frame
before treatment
Title
Oxidative stress response index
Description
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.
Time Frame
on the 7th day of treatment
Title
Renal function index
Description
The renal function indexs before treatment were detected before the 7th day of treatment.
Time Frame
before of treatment
Title
Renal function index
Description
The renal function indexs after treatment were detected on the 7th day of treatment.
Time Frame
on the 7th day of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Facility Information:
Facility Name
Wen-Ming Feng
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Analysis of Vitamin B6 in Sepsis

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