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临床试验/NCT06008223
NCT06008223已完成不适用

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

The First People's Hospital of Huzhou1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Renal function index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

experimental group (vitamin B6)

Experimental

干预措施: vitamin B6 (Drug)

control group (0.9% sodium chloride solution)

Placebo Comparator

干预措施: 0.9% sodium chloride solution (Drug)

结局指标

主要结局

Renal function index

时间窗: on the 7th day of treatment

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

Inflammatory response index

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
The First People's Hospital of Huzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Ming Feng

Principal investigator

The First People's Hospital of Huzhou

研究点 (1)

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