The effect of preoperative intravenous mannitol injection in reducing acute kidney injury following percutaneous nephrolithotomy

Prevention of reduction in renal function after percutaneous nephrolithotomy. Improvement in renal function after percutaneous nephrolithotomy. To compare complications of percutaneous nephrolithotomy in case and control groups

Randomised clinical trial including 75 patients in 2 parallel case and control groups ; triple blinded (patients , surgeon and data analyzer were all blind),Randomised with balanced block randomization table.

150 patients 18-75 years of age who are candidates for percutaneous nephrolithotomy (PCNL) referring to Hasheminejad Kidney Center will be randomly divided into 2 groups of 75 patients. In the intervention group 15 minutes before surgery 25 g intravenous mannitol will be injected. In the control group no mannitol will be injected. Glomerular filtration rate (GFR) will be measured using the cockroft gault equation based on creatinine levels on the day before surgery, 6 hours after surgery, 1, 2, and 14 days after surgery. In this study, the surgeon, the static analyzer, the data collector, and the patients will be blinded to injection of mannitol.

Patients candiate for percutaneous nephrolithotomy between 18 to 75 years old; without history of deep vein thrombosis, emboli, brain edema, high intracranial pressure, digoxin user, and lithium user, coagolopathies, Heart failure

In case group, 15 minutes before percutaneous nephrolithotomy, 25 grams of mannitol solution will be injected intravenously. In control group, non mannitol serum will be injected.

Glomerular filtration rate changes, Serum hemoglobin level changes, Complications of the surgery in both groups

َAccording 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.

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.

All data can potentially be shared after hiding patients identity

18 months after article publication, data is available

Only for researches in universities and academic institutions

No other condition is needed

Mohammadmehdi Atarod 00989120233308 dr.atarod@gmail.com

After receiving an email based on the need to access the data of this article, respond will be sent within 30 work days