Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Obstructive Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928286
• Other study ID #: Remaxol\2022\02
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: POLYSAN Scientific & Technological Pharmaceutical Company
• Contact: Alexey Kovalenko, Doc Biol Sci
• Phone: +78127108225
• Email: science[@]polysan.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent form.

2. Age from 18 to 70 years

3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.

4. Total bilirubin level in the blood in the range from 102.5 to 246 µmol/l.

5. Jaundice duration according to the patient is not more than 7 days.

6. Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopic cholecystectomy.

Exclusion Criteria:

1. Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).

2. Acute cholangitis. Acute cholecystitis. Acute pancreatitis.

3. History of chronic viral hepatitis, hepatic cirrhosis.

4. Other surgical pathology aggravating the condition and/or requiring treatment.

5. Use in the treatment of drugs containing ademethionine.

6. CHF, functional class III-IV according to NYHA.

7. History of chronic kidney disease and/or creatinine level of more than 130 µmol/l.

8. Respiratory failure.

9. Impairment of consciousness.

10. Diabetes mellitus.

11. Psychic diseases.

12. Autoimmune diseases.

13. Tuberculosis, HIV infection.

14. Pregnancy, lactation.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone Disease
• Gallstones
• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice

Intervention

Drug:
• Remaxol
The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid)

Locations

Country	Name	City	State
Russian Federation	Krai Clinical Hospital	Barnaul
Russian Federation	Hospital for War Veterans	Kazan
Russian Federation	City Clinical Hospital No. 7	Nizhny Novgorod
Russian Federation	Pavlov Ryazan State Medical University	Ryazan
Russian Federation	St. Elizabeth Hospital	Saint Petersburg
Russian Federation	Samara State Medical University	Samara
Russian Federation	Mirotvortsev University Clinical Hospital No. 1	Saratov
Russian Federation	Dzhanelidze St. Petersburg Research Institute of Emergency Medicine	St. Petersburg
Russian Federation	Kuvatov Republican Clinical Hospital	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
POLYSAN Scientific & Technological Pharmaceutical Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l and lower by the end of hospitalization	Decrease of total bilirubin level down to 20.5 µmol/l and lower by the end of hospitalization , after successful common bile duct decompression.	Up to 2 weeks
Secondary	Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy	Decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy, after successful common bile duct decompression.	Up to 2 weeks
Secondary	Complication rate in the postoperative period	Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications	Up to 2 weeks
Secondary	Total hospitalization duration in days (in case of two-staged surgical treatment).	Total hospitalization duration in days	Up to 2 weeks
Secondary	Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.	Total hyperbilirubinemia duration (in days) after the beginning of fluid administration	Up to 2 weeks
Secondary	Interval (in days) between surgical interventions	Interval (in days) between surgical interventions	Up to 2 weeks
Secondary	Change of hepatic function tests (AST,)	Change of hepatic function tests (AST) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of hepatic function tests ( ALT)	Change of hepatic function tests (ALT) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of hepatic function test ( AP)	Change of hepatic function test ( AP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of hepatic function test (GGTP)	Change of hepatic function test (GGTP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of hepatic function tests (protein, albumin, fibrinogen)	Change of hepatic function tests (protein, albumin, fibrinogen) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of PTI	Change of PTI relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of renal function test (urea)	Change of renal function test (urea) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Change of renal function test (creatinine)	Change of renal function test (creatinine) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.	Baseline, on the day after surgery, up to 2 weeks
Secondary	Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.	Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.	Up to 2 weeks