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

ِDetermining the effect of intranasal desmopressin on the bleeding complications after renal biopsy

Phase 3, Two arm, parallel-group , double-blind, randomized controlled trial on 60 subjects

Nephrology ward of Nemazee hospital was the location. We will enroll patients who are referred to Nemazee hospital's nephrology ward for elective renal biopsy. The patients who fill the consent form and are at least 16 years old will be considered. The researcher, the person who performs the biopsy, the nurses who administer the sprays, and the patients will be blinded about the type of treatments.

Inclusion criteria: Patients referred for renal biopsy. Non-inclusion criteria: abnormal renal function.

The intervention group will receive high-concentration desmopressin spray nasally one hour before the renal biopsy. The control group will receive saline spray nasally one hour before the biopsy. 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. The control group will receive saline spray 0.65 percent nasally one hour before the biopsy (RINOSALTIN®, Sina Darou, Iran). 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 medication and the placebo are both prescribed once.

The proportion of patients who develop hematoma; The proportion of patients who develop hematuria.

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.

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.

All participants' personal data can be shared after de-identification.

The start of the data access period can be immediately after the results are published.

The data will be available to researchers working in academic and scientific institutions.

There is no more condition.

By contacting the study presenter Shahrokh Ezzatzadegan, email shjahromi@sums.ac.ir

After receiving the request by email, the data will be sent immediately.