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IRCT20200110046073N1 IRCT 2020-03-01 Iran University of Medical Sciences The effect of preoperative intravenous mannitol injection in reducing acute kidney injury following percutaneous nephrolithotomy The effect of preoperative intravenous mannitol injection in reducing acute kidney injury following percutaneous nephrolithotomy 2020-03-04 anticipated 150 Complete https://irct.ir/trial/45012 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: ŮŽAccording to a Balance block randomization table prepared for 150 patients with statistical software, 75 patients will be in case and the rest will be in the control group randomly. This table will be just given to the anesthesiologist who is the only person who knows the patient group. All patients who have the criteria of this study will be placed in one of the case or control group respectively as the come to the operating room according to the Balance block randomization table by the anesthesiologist . Each patient has a form with a number at the top which does not show the group of patient. All the data except for the group of the patients will be inserted to an SPSS form by one person and the group will be inserted in a 0 and 1 manner in another SPSS form by another person and then will be copied to the first SPSS form. Data analyser will not be informed of the group of patients and will know them as group 0 and 1. After analysis finnished, we will have access to the type of 0 and 1 group according to the person who inserted the data of group type in the SPSS form, Blinding description: Patients, data collector and analyzer, and the researcher will be all blinded to injection of mannitol. It will be done according to the balance block randomization table by Anesthesiologist. 3 Acute kidney injury, Renal stone, Percutaneous nephrolithotomy (PCNL). Intervention 1: Intervention group: Interavenous injection of 25 grams of mannitol (125 cc of 20% mannitol Serum) in 75 patients candidated for percutaneous nephrolithotomy, 15 minutes before surgery. Intervention 2: Control group: Interavenous injection of 125 cc of Non mannitol Serum in 75 patients candidated for percutaneous nephrolithotomy, 15 minutes before surgery. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after hiding patients identity When: 18 months after article publication, data is available To whom: Only for researches in universities and academic institutions Conditions: No other condition is needed Where to obtain: Mohammadmehdi Atarod 00989120233308 dr.atarod@gmail.com How to obtain: After receiving an email based on the need to access the data of this article, respond will be sent within 30 work days Comments:
public Kaveh Mehravaran
Vanak sq- Valiasr st- Valinejad st- Hasheminejad Kidney Center Hospital
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8864 4441 Mehravarankaveh@yahoo.com Iran University of Medical Sciences scientific Kaveh Mehravarn
Vanak sq- Valiasr st- Valinejad st- Hasheminejad Kidney Center Hospital
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8864 4441 Mehravarankaveh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with renal stone greater than 20 mm in diameter who are candidated for percutaneous nephrolithotomy. Patients with proximal ureter stone greater than 20 mm in diameter who are candidated for percutaneous nephrolithotomy. 18 years 75 years Both Heart failure History of lung embolism History of deep vein thrombosis History of brain edema History of intracranial hemorrhage Respiratory edema Anuria History of digoxin consumption History of Lithium consumption History of allergy to mannitol Electrolite imbalance Coagolopathies N99.0 Postprocedural (acute) (chronic) kidney failure Prevention Placebo Intervention group: Interavenous injection of 25 grams of mannitol (125 cc of 20% mannitol Serum) in 75 patients candidated for percutaneous nephrolithotomy, 15 minutes before surgery Control group: Interavenous injection of 125 cc of Non mannitol Serum in 75 patients candidated for percutaneous nephrolithotomy, 15 minutes before surgery. Post percutaneous nephrolithotomy glomerular filtration rate changes. Timepoint: The day before surgery, 6 hours after surgery, 1, 2, and 14 days after surgery. Method of measurement: cockroft gault equation (based on serum creatinine level). Post operative hemoglobin changes. Timepoint: The day before surgery, 6 hours after surgery, 1, 2, and 14 days after surgery. Method of measurement: Complete blood count. Post operative infection. Timepoint: The day before surgery, 6 hours after surgery, 1, 2, and 14 days after surgery. Method of measurement: Thermometer. Iran University of Medical Sciences Approved 2020-02-24 Ethics committee of Iran University of Medical Sciences Vanak sq- Valiasr st- Valinejad st- Hasheminejad Kidney Center Hospital Tehran Tehran Iran (Islamic Republic of)