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IRCT20230228057568N1 IRCT 2023-03-05 Gorgan University of Medical Sciences Comparison of noradrenaline with the combination of octreotide and midodrine in the treatment of hepatorenal syndrome type 1 Comparison of the Effectiveness of noradrenaline with the combination of octreotide and midodrine in the treatment of hepatorenal syndrome type 1 2023-03-21 anticipated 50 Complete https://irct.ir/trial/68951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: In order to randomize samples, we use a block method with quadrilateral blocks. In this way, one of the following blocks is first selected by accident (for example, with a dice), and according to the order in which those samples are We assign two groups (A for the group receiving Noradrenaline and B for the Standard treatment group). For example, if block 3 is selected and the first one is assigned to the group receiving the Noradrenaline, and the second and third samples will be allocated to the Standard treatment recipient group, the fourth will be assigned to the group receiving the Noradrenaline. Then for four samples, again, a block will be randomly selected. We will allocate it to it and this process will proceed to the end of the sampling, Blinding description: The study is double-blind. In this way, all the patients and the student facilitator evaluating the designed interventions (internal medicine assistant, project manager) in the study or the outcomes after the project (internal medicine assistant and nephrology specialist) will not know about the study groups. 3 Hepatorenal Syndrome. Intervention 1: Intervention group: Patients receiving Noradrenaline and Albumin treatment/ In this group, patients with Hepatorenal Syndrome were treated with Noradrenaline at an initial dose of 1 mg/h with continuous injection and then gradually increased to a maximum dose of 4 mg/h in order to achieve a minimum urine output of at least 400 ml per 12 hours + Receiving Albumin on the first day of 1 gram per kilogram of body weight and then 20 to 40 grams per day intravenously for up to 14 days/ basic and clinical and laboratory information in both groups at the beginning and then on days 1, 3, 7, and 14 and the maximum time Readmission will be checked. Intervention 2: Control group: standard treatment of patients with Midodrine, Octreotide and albumin (receive Midodrine orally with an initial dose of 7.5 mg three times a day, with a dose increase up to a maximum of 12.5 mg three times a day, together with Octreotide subcutaneously: initial dose 100 μg three times a day and up to 200 μg three times a day +Receiving Albumin on the first day of 1 gram per kilogram of body weight and then 20 to 40 grams per day intravenously for up to 14 days / basic and clinical and laboratory information in both groups at the beginning and then on days 1, 3, 7, and 14 and the maximum time Readmission will be checked. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: There are no restrictions to perform statistical analyzes and access to data and documents. elated additional documents such as study protocol, data analysis program, etc. will also be shared. Where to obtain: Dr. Maryam Maqsoodlou: internal resident/ phone number: 09113759570/ Email: maryamm.maqsoudl1367.com/ postal code: 4913983794/ address: Number 11, Aseman building, Shahriar Alley 5, Shahriar Blvd, Shahryar town, Gorgan city How to obtain: The applicant should provide his / her study file and the purpose of receiving the data in the form of an email with his / her research file (research plan), then after 3 months the file will be provided to the person Comments:
public Maryam Maqsoudloo
Number 11, Aseman building, Shahriar Alley 5, Shahriar Blvd, Shahryar town
Gorgan Iran (Islamic Republic of) 49178677439 +98 17 3262 5346 maryamm.maqsoudl1367@gmail.com Gorgan University of Medical Sciences scientific Dr. Saeed Amirkhanlou
Nephrology's Clinic and Obstetrics and Gynecology Department, 2nd floor, Shahid Sayad Shirazi Hospital, Sayad Shirazi Blvd., Bahonar Square, Gorgan, Iran
Gorgan Iran (Islamic Republic of) 4915663158 +98 17 3226 1175 drsam74ir@ymail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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. K76.7 Hepatorenal syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving Noradrenaline and Albumin treatment/ In this group, patients with Hepatorenal Syndrome were treated with Noradrenaline at an initial dose of 1 mg/h with continuous injection and then gradually increased to a maximum dose of 4 mg/h in order to achieve a minimum urine output of at least 400 ml per 12 hours + Receiving Albumin on the first day of 1 gram per kilogram of body weight and then 20 to 40 grams per day intravenously for up to 14 days/ basic and clinical and laboratory information in both groups at the beginning and then on days 1, 3, 7, and 14 and the maximum time Readmission will be checked. Control group: standard treatment of patients with Midodrine, Octreotide and albumin (receive Midodrine orally with an initial dose of 7.5 mg three times a day, with a dose increase up to a maximum of 12.5 mg three times a day, together with Octreotide subcutaneously: initial dose 100 μg three times a day and up to 200 μg three times a day +Receiving Albumin on the first day of 1 gram per kilogram of body weight and then 20 to 40 grams per day intravenously for up to 14 days / basic and clinical and laboratory information in both groups at the beginning and then on days 1, 3, 7, and 14 and the maximum time Readmission will be checked. 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. Treatment of hepatorenal syndrome and mortality rate. Timepoint: Beginning and end of day 14. Method of measurement: Blood/urine samples and bedside examination. Gorgan University of Medical Sciences Approved 2022-11-27 Ethics Committee of Golestan University of medical sciences Golestan University of Medical Sciences Research Office, The beginning of Shast Kolah Road, Hirkan Blvd, Basij Square Gorgan Golestan Iran (Islamic Republic of)