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IRCT20201019049075N2 IRCT 2021-09-11 Shiraz University of Medical Sciences Evaluation of the effect of intranasal desmopressin spray on complications of kidney biopsy Randomized Placebo-controlled trial of the effect of intranasal administration of desmopressin acetate on the bleeding complications after renal needle-biopsy sampling in patients with normal renal function 2019-04-04 anticipated 60 Complete https://irct.ir/trial/53238 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The random allocation method in this study will be the permuted block technique. The permuted block technique randomizes patients between groups within a set of study participants, called a block. In this trial, which is performed on two groups with a 1:1 allocation ratio and a block size of 4, the total number of possible 4 permutations is equal to 6. If A is the label used for the intervention group and B for the placebo group, the possible blocks might be ABAB, BABA, AABB, BBAA, ABBA, BAAB. Then, using a table of random numbers and assigning the code zero to 9 to each of the permutations, a random list of 60 numbers, which includes 15 blocks of 4 (4 * 15 = 60 total number of samples), is generated and the order, in which each of the subjects is assigned to the two study groups, is determined. For example; AABB Code 0, BABA Code 1, AABB Code 2, BBAA Code 3, BAAB Code 4, and ABBA Code 5 to 9. Then, by using a table of random numbers, the starting point is randomly selected and 15 numbers are randomly chosen (in row or column) and the permutation assigned to each number is recorded. The order of placement of permutations will be from left to right, therefore, allocation of all 60 subjects to the two groups A and B will be determined, Blinding description: This study would be a double-blind trial. The principle investigator provides one of the research nurses with the randomization list of the assignment of individuals to the two groups. The nurse who randomly places patients into two groups is different from the nurse who prescribes medication. The labels of desmopressin sprays, as well as the placebos, are covered. Therefore, the lead researcher, the prescribing nurse, and the patients will not be informed of the allocation. The person evaluating the study will be completely different from the staff involved in the medication prescribing process. Therefore, the radiologist who performs the ultrasound is unaware of the patients’ allocation. Only the statistician saw unblinded data. 3 Condition 1: Bleeding. Condition 2: Kidney biopsy. Intervention 1: The intervention group: The intervention group will receive high-concentration desmopressin spray nasally Octostim® (concentration of 150 micrograms per milliliter) (Ferring GmbH, Germany) one hour before the renal biopsy. The dose is dependent on the patient's weight; patients weighing less than 50 kilograms, 150 micrograms (one nasal spray) per dose; patients weighing more than 50 kg, 300 micrograms (two nasally sprays one per nostril) per dose. Intervention 2: Control group: The control group will receive RINOSALTIN® nasal spray (0.65 percent saline spray) ( Sina Darou, Iran) nasally one hour before the biopsy. The dose is dependent on the patient's weight; patients weighing less than 50 kilograms one nasal spray per dose; patients weighing more than 50 kg, two nasally sprays one per nostril per dose. Yes - There is a plan to make this available What will be shared: All participants' personal data can be shared after de-identification. When: The start of the data access period can be immediately after the results are published. To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: There is no more condition. Where to obtain: By contacting the study presenter Shahrokh Ezzatzadegan, email shjahromi@sums.ac.ir How to obtain: After receiving the request by email, the data will be sent immediately. Comments:
public Shahrokh Ezzatzadegan Jahromi
Department of Internal Medicine, Nemazee Hospital, Nemazee Square, Zand street
Shiraz Iran (Islamic Republic of) 7193737485 +98 71 3647 4316 shjahromi@sums.ac.ir Shiraz University of Medical Sciences scientific Shahrokh Ezzatzadegan Jahromi
Department of Internal Medicine, Nemazee Hospital, Nemazee Square, Zand street
Shiraz Iran (Islamic Republic of) 7193737485 +98 71 3647 4316 shjahromi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients referred for renal biopsy. 16 years no limit Both Blood pressure more than 160/90 mmhg, Abnormal kidney function (serum creatinine more than 1.5 mg/dl and GFR less than 60 cc/min by CKD-EPI formula), Serum sodium less than 130 meq/liter, Taking anti-platelets or anticoagulants Thrombocytopenia History of kidney cancer Solitary kidney Small size kidneys Active urinary tract infection Abnormal prothrombin time L76.22 Postprocedural hemorrhage and hematoma of skin and subcutaneous tissue following other procedure Treatment - Drugs Placebo The intervention group: The intervention group will receive high-concentration desmopressin spray nasally Octostim® (concentration of 150 micrograms per milliliter) (Ferring GmbH, Germany) one hour before the renal biopsy. The dose is dependent on the patient's weight; patients weighing less than 50 kilograms, 150 micrograms (one nasal spray) per dose; patients weighing more than 50 kg, 300 micrograms (two nasally sprays one per nostril) per dose. Control group: The control group will receive RINOSALTIN® nasal spray (0.65 percent saline spray) ( Sina Darou, Iran) nasally one hour before the biopsy. The dose is dependent on the patient's weight; patients weighing less than 50 kilograms one nasal spray per dose; patients weighing more than 50 kg, two nasally sprays one per nostril per dose. The proportion of the patients who develop hematoma. Timepoint: 24 hours after biopsy. Method of measurement: Ultrasound. The proportion of the patients who develop hematuria. Timepoint: 24 hours after biopsy. Method of measurement: Urinalysis. Shiraz University of Medical Sciences Approved 2019-03-12 Ethics Committee in Research, School of Medicine, Shiraz University of Medical Sciences Vice Chancellor for Research, 3rd Floor, Building No.3, Shiraz Medical School, Imam Hossein Square, Zand St., Tel. No.: 07132349333 Shiraz Fars Iran (Islamic Republic of)