NCT05928286已完成不适用
Observational Study of Efficiency of the Drug Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic Acid) Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
POLYSAN Scientific & Technological Pharmaceutical Company18 个研究点 分布在 2 个国家目标入组 286 人开始时间: 2022年12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
- 入组人数
- 286
- 试验地点
- 18
- 主要终点
- Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
研究概览
简要总结
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Age from 18 to 80 years
- •Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
- •Total bilirubin level in the blood in the range from 60 to 246 µmol/l.
- •Jaundice duration according to the patient is not more than 7 days.
- •Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopic cholecystectomy.
排除标准
- •Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).
- •Acute cholangitis. Acute cholecystitis. Acute pancreatitis.
- •History of chronic viral hepatitis, hepatic cirrhosis.
- •Other surgical pathology aggravating the condition and/or requiring treatment.
- •Use in the treatment of drugs containing ademethionine.
- •CHF, functional class III-IV according to NYHA.
- •History of chronic kidney disease and/or creatinine level of more than 130 µmol/l.
- •Respiratory failure.
- •Impairment of consciousness.
- •Diabetes mellitus.
- •Psychic diseases.
- •Autoimmune diseases.
- •Tuberculosis, HIV infection.
- •Pregnancy, lactation.
研究组 & 干预措施
The test group
Standard therapy + Remaxol
干预措施: Remaxol (Drug)
The control group
Standard therapy
结局指标
主要结局
Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
时间窗: Up to 2 weeks
Decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
次要结局
- Total hospitalization duration in days (in case of two-staged surgical treatment).(Up to 2 weeks)
- Change of hepatic function tests (AST,)(Baseline, on the day after surgery, up to 2 weeks)
- Change of hepatic function test ( AP)(Baseline, on the day after surgery, up to 2 weeks)
- Change of hepatic function test (GGTP)(Baseline, on the day after surgery, up to 2 weeks)
- Change of renal function test (urea)(Baseline, on the day after surgery, up to 2 weeks)
- Change of hepatic function tests ( ALT)(Baseline, on the day after surgery, up to 2 weeks)
- Change of hepatic function tests (protein, albumin, fibrinogen)(Baseline, on the day after surgery, up to 2 weeks)
- Change of PTI(Baseline, on the day after surgery, up to 2 weeks)
- Change of renal function test (creatinine)(Baseline, on the day after surgery, up to 2 weeks)
- Complication rate in the postoperative period(Up to 2 weeks)
- Interval (in days) between surgical interventions(Up to 2 weeks)
- Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy(Up to 2 weeks)
- Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.(Up to 2 weeks)
- Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.(Up to 2 weeks)
研究者
研究点 (18)
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