Determination of the Preventive Effect of Desmopressin Acetate on the incidence of bleeding complications following kidney biopsy in patients with renal disease
Determining the preventive effect of desmopressin acetate on the occurrence of bleeding complications following renal biopsy in patients undergoing renal biopsy
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 120 patients. Excel software rand function was used for randomization
Settings and conduct
This study was a randomized clinical trial on 120 biopsy candidates referred to Golestan and Imam Hospitals of Ahvaz University of Medical Sciences. In this study, 60 patients received desmopressin and 60 patients received placebo. The study was performed as a double-blind study. In this way, the patients participating in the study and the treatment staff were unaware of the type of drug given to the participants in the study.
Participants/Inclusion and exclusion criteria
Exclusion criteria : Systrelic Blood Pressure Time Biopsy less than160mmhg Diastolic BP Time to do biopsy less than100mmhg Single kidney Kidney cancer Renal hydronephrosis Renal Pyrenophore Small size Significant kidneys in ultrasound Severe obesity Hemoglobin less than 11 Sodium concentration in serum less than 120 Primary phenotypes Renal transplantation Multiple cysts in both kidneys
inclusion criteria: People 18 years and older 15≤GFR≤90 cc/min/1.73 m2 according MDRD formula
Intervention groups
Intervention group: In this group, 60 patients received 0.3 μg / kg desmopressin acetate (Ferring GmbH Keil, Germany) intranasally 1 hour before biopsy.
Placebo group: In this group, 60 patients received 0.65% sodium chloride 1cc/kg (Raha Pharmaceutical Company) intranasally 1 hour before biopsy.
Main outcome variables
Kidney biopsy will be evaluated immediately after taking the sample and 24 hours after it and in case of hematoma 48-72 hours later by ultrasound.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090701002112N3
Registration date:2020-10-04, 1399/07/13
Registration timing:retrospective
Last update:2020-10-04, 1399/07/13
Update count:0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Ali Ghorbani
Name of organization / entity
Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 5154
Email address
ghorbani-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2020-01-25, 1398/11/05
Trial completion date
2020-05-23, 1399/03/03
Scientific title
Determination of the Preventive Effect of Desmopressin Acetate on the incidence of bleeding complications following kidney biopsy in patients with renal disease
Public title
Determination of the Preventive Effect of Desmopressin Acetate on the incidence of bleeding complications following kidney biopsy in patients with renal disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People 18 years and older
15≤GFR≤90 cc/min/1.73 m2 according MDRD formula
Exclusion criteria:
Disrupted coagulation profile (including disruption in any of the PT tests, INR, PTT, and platelet counts are less than 50000
Systrelic Blood Pressure Time Biopsy less than160mmhg
Diastolic BP Time to do biopsy less than100mmhg
Single kidney
Kidney cancer
Renal hydronephrosis
Renal Pyrenophore
Small size Significant kidneys in ultrasound
Severe obesity
Hemoglobin less than 11
Sodium concentration in serum less than 120
Primary phenotypes
Renal transplantation
Multiple cysts in both kidneys
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
146
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups A and B. Block randomization methods were used. The size of the block was four and in each block 2 patient in group A and 2 patient in group B were assigned. The order of groups A and B within each block was determined randomly using function (RAND) in Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the interventionist and the person examining the results did not know what group the individuals were in, and the study would be double blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Jundishapur University of Medical Sciences (AJUMS)
Street address
Ahvaz Jndishapour University of Medical Sciences, Golestan blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.AJUMS.REC.1394.264
Health conditions studied
1
Description of health condition studied
Chronic kidney patients
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
Hematoma
Timepoint
Immediately after receiving a kidney biopsy specimen and 24 hours later, and in the event of a hematoma, 48-72 hours later
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Hematuria
Timepoint
After biopsy
Method of measurement
View at any time urinating
2
Description
Vital signs l (blood pressure and heart rate)
Timepoint
Every 15 minutes for 2 hours, then every 1 hour for 4 hours, then every 2 hours for 6 hours, and then every 4 hours
Based on the block of redundancy and the patient in the intervention group, 1 hour before biopsy, desmopressin acetate is received in the nose and 1 kg / kg. After 1 hour, the ultrasound ultrasound radiologist will perform ultrasound with supine and needl
Category
Prevention
2
Description
Based on the rate of redundancy and the fact that the patient is in the control group, 1 hour before biopsy, 0.6 kg / kg sodium chloride receives intranasal. After 1 hour, the ultrasound ultrasound radiologist will perform ultrasound with supine and needl
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Department of Imam Khomeini Hospital and Ahvaz Golestan
Full name of responsible person
Dr Ali Ghorbani
Street address
Jundishapur University of Medical Sciences, olestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Golestanjpsital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz, Jundishapur University of Medical Sciences, Ahwaz, Golestan Blvd., Esfand Avenue
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Fax
Email
Info@Ajums.Ac.Ir
Grant name
Ahwaz University of Medical Sciences
Grant code / Reference number
U-95038
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ali Ghorbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Jundishapur University of Medical Sciences, olestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
Email
ghorbani-a@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ali Ghorbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3013
Fax
Email
ghorbani-a@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ali Ghorbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3013
Fax
Email
ghorbani-a@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available