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IRCT20191009045037N1 IRCT 2019-11-30 Shahre-kord University of Medical Sciences The effect of injectable albumin on renal and coagulation system activity Comparison of the Effect of 5% Albumin Infusion with Ringer Lactate Serum on Replacement of Patients' Bleeding during Surgery on the Function of Renal and Coagulation System and Their Electrolytes after Surgery 2017-10-23 anticipated 80 Complete https://irct.ir/trial/42869 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to Albumin 5% or Ringer lactate. Random assignment will be done using a random number table, Blinding description: The participant was under general anesthesia during the intervention and the outcome assessor and analyzer received the results of the study as group A and B and were not aware of Albumin group. 3 Condition 1: Chronic kidney disease. Condition 2: Coagulapathy. Intervention 1: Intervention group: Intraoperative fluid therapy in the this group would be albumin 5% equal to bleeding volume. To study patients' coagulation status, Prothrombin time (PT), Partial thromboplastin time (PPT), and INR tests. Measurements will be at preoperative times, at 6, 12, and 24 hours after surgery. In addition , concentrations of electrolytes (sodium, potassium and calcium), urinary output, BUN and creatinine will also be collected. Intervention 2: Control group: Intraoperative fluid therapy in the this group would be Ringer lactate with three times of bleeding volume. To study patients' coagulation status, Prothrombin time (PT), Partial thromboplastin time (PPT), and INR tests. Measurements will be at preoperative times, at 6, 12, and 24 hours after surgery. In addition , concentrations of electrolytes (sodium, potassium and calcium), urinary output, BUN and creatinine will also be collected. Yes - There is a plan to make this available What will be shared: Clinical characteristics and laboratory information of patients, sample collection method, inclusion and exclusion criteria, intraoperative bleeding, intraoperative fluid therapy, pre- and postoperative tests, information analysis method and information results When: 2020 To whom: Ministry of Health and Medical Education of the Islamic Republic of Iran Conditions: For information on appropriate treatment and permission from the research officer Where to obtain: From researcher hosseinmadineh@gmail.com and Shahrekord University of Medical Sciences:   info@skums.ac.ir : How to obtain: Documentary Requirements for Information Required and Letter from his Affiliated Institution After Investigating If a Researcher and Shahrekord University of Medical Sciences Agree Within a Month Comments:
public Hossein Madineh
Parrastar St
Shahrekord Iran (Islamic Republic of) ۸۸۱۶۷۵۸۹۱۵ +98 38 3226 4835 hosseinmadineh@gmail.com Shahre-kord University of Medical Sciences scientific Hossein Madineh
Parrastar St
Shahrekord Iran (Islamic Republic of) ۸۸۱۶۷۵۸۹۱۵ +98 38 3226 4835 hosseinmadineh@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Men and women 18 to 75 years The risk of anesthesia is 1 or 2 with the division of the American Anesthesia Association A blood urea of less than 38.5 mg / dl Have a blood creatinine of less than 1.3 mg / dL Blood platelets range between 150,000 and 300,000 Patient INR less than 1.2 The patient's consent form must be signed by the patient 18 years 75 years Both Patient with a history of liver disease Patient with a history of heart failure Patient history of kidney disease Patient with a history of coagulopathy N18 D68.9 Chronic kidney disease (CKD) Coagulation defect, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intraoperative fluid therapy in the this group would be albumin 5% equal to bleeding volume. To study patients' coagulation status, Prothrombin time (PT), Partial thromboplastin time (PPT), and INR tests. Measurements will be at preoperative times, at 6, 12, and 24 hours after surgery. In addition , concentrations of electrolytes (sodium, potassium and calcium), urinary output, BUN and creatinine will also be collected. Control group: Intraoperative fluid therapy in the this group would be Ringer lactate with three times of bleeding volume. To study patients' coagulation status, Prothrombin time (PT), Partial thromboplastin time (PPT), and INR tests. Measurements will be at preoperative times, at 6, 12, and 24 hours after surgery. In addition , concentrations of electrolytes (sodium, potassium and calcium), urinary output, BUN and creatinine will also be collected. The effect of albumin on renal system activity. Timepoint: Preoperatively and 6, 12 and 24 hours postoperatively. Method of measurement: Calometric. The effect of albumin on coagulation activity. Timepoint: Preoperatively and 6,12,24 hours postoperatively. Method of measurement: Coagulometer. Shahre-kord University of Medical Sciences Approved 2017-01-21 Ethics committee of Shahrekord University of Medical Sciences Ayatollah Kashani Ave Shahrekord University of Medical Sciences 8815713471 Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)