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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Jaundice; Gallstone Disease
• Intervention / Treatment: Drug: Remaxol

• Study Type: Observational
• Enrollment (Estimated): 286

Contacts and Locations

• Study Contact: Name: Alexey Kovalenko, Doc Biol Sci; Phone Number: 212 +78127108225; Email: science@polysan.ru

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The control group; Standard therapy
The test group; Standard therapy + Remaxol	Drug: Remaxol; The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complication rate in the postoperative period	Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications	Up to 2 weeks
Total hospitalization duration in days (in case of two-staged surgical treatment).	Total hospitalization duration in days	Up to 2 weeks
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
Interval (in days) between surgical interventions	Interval (in days) between surgical interventions	Up to 2 weeks
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Obstructive jaundice; Gallstone disease; Remaxol
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Skin Manifestations; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Hyperbilirubinemia; Gallstones; Cholelithiasis; Cholecystolithiasis; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: Remaxol\2022\02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No