Clinical trial NCT05928286: Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gallstone Disease
Obstructive Jaundice
Keywords: Gallstone disease
Obstructive jaundice
Remaxol
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy
timeFrame: Up to 2 weeks
measure: Complication rate in the postoperative period
timeFrame: Up to 2 weeks
measure: Total hospitalization duration in days (in case of two-staged surgical treatment).
timeFrame: Up to 2 weeks
measure: Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.
timeFrame: Up to 2 weeks
measure: Interval (in days) between surgical interventions
timeFrame: Up to 2 weeks
measure: Change of hepatic function tests (AST,)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of hepatic function tests ( ALT)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of hepatic function test ( AP)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of hepatic function test (GGTP)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of hepatic function tests (protein, albumin, fibrinogen)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of PTI
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of renal function test (urea)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Change of renal function test (creatinine)
timeFrame: Baseline, on the day after surgery, up to 2 weeks
measure: Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Krai Clinical Hospital
city: Kazan
country: Russian Federation
facility: Hospital for War Veterans
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital No. 7
city: Ryazan
country: Russian Federation
facility: Pavlov Ryazan State Medical University
city: Saint Petersburg
country: Russian Federation
facility: St. Elizabeth Hospital
city: Samara
country: Russian Federation
facility: Samara State Medical University
city: Saratov
country: Russian Federation
facility: Mirotvortsev University Clinical Hospital No. 1
city: St. Petersburg
country: Russian Federation
facility: Dzhanelidze St. Petersburg Research Institute of Emergency Medicine
city: Ufa
country: Russian Federation
facility: Kuvatov Republican Clinical Hospital
Study officials:
References: