Comparison of noradrenaline with the combination of octreotide and midodrine in the treatment of hepatorenal syndrome type 1
Phase 3
- Conditions
- Hepatorenal Syndrome.Hepatorenal syndromeK76.7
- Registration Number
- IRCT20230228057568N1
- Lead Sponsor
- Gorgan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Diagnosis based on modified HRS diagnostic criteria in 2007: Cirrhosis with ascites and increased serum creatinine level (>1.5 mg/dL) with non-recovery up to 48 hours after diuretic discontinuation and volume increase with albumin
Absence of shock
Not receiving nephrotoxic drugs
Absence of kidney parenchymal disease or obstructive uropathy in laboratory and ultrasound assessment
Doubling of creatinine level to more than 2.5 mg/dL in 2 weeks or less
Exclusion Criteria
History of coronary disease and evidence of ventricular arrhythmia or cardiomyopathy obtained based on history taking, assessment of risk factors, physical examination, echocardiography and radiography.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of serum creatinine level below 1.5 mg. Timepoint: Before the intervention and days 1, 3, 7 and 14. Method of measurement: Blood and urine samples.;Increase in 4-hour urine output above 200 ml. Timepoint: Before the intervention and days 1, 3, 7 and 14. Method of measurement: Blood and urine samples.;Statistically significant improvement in serum creatinine and sodium levels. Timepoint: Before the intervention and days 1, 3, 7 and 14. Method of measurement: Blood and urine samples.
- Secondary Outcome Measures
Name Time Method Treatment of hepatorenal syndrome and mortality rate. Timepoint: Beginning and end of day 14. Method of measurement: Blood/urine samples and bedside examination.