| CTRI Number |
CTRI/2022/03/041038 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess whether desmopressin reduces complications in patients with kidney dysfunction undergoing renal biopsy |
|
Scientific Title of Study
|
Role of desmopressin in renal biopsy in patients with renal dysfunction (CKD-EPI with GFR < 45ml/min) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandep Bansal |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal Medicine
PGIMER Chandigarh
Chandigarh
CHANDIGARH
151002
India |
| Phone |
9896875989 |
| Fax |
|
| Email |
sandeepbansal2001@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Rathi |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal Medicine
PGIMER Chandigarh
Chandigarh
CHANDIGARH
151002
India |
| Phone |
9216721287 |
| Fax |
|
| Email |
drmanishrathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandep Bansal |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal Medicine
PGIMER Chandigarh
Chandigarh
CHANDIGARH
151002
India |
| Phone |
9896875989 |
| Fax |
|
| Email |
sandeepbansal2001@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER research GRANT |
| Address |
PGIMER CHANDIGARH |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Bansal |
PGIMER, Chandigarh |
Biopsy Room,
Department of Nephrology
Chandigarh
CHANDIGARH |
9896875989
sandeepbansal2001@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desmopressin |
Dose- 150 microgram
Route- intranasal route
only single dose before biopsy |
| Comparator Agent |
Normal saline |
Route- Intranasally
single dose before biopsy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. eGFR less than 45 ml per minute.
2. Those who give informed consent. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Post renal transplant patient
Uncontrolled hypertension
Haemoglobin< 8 gm/dl
Platelet count < 85,000/μL
Active bleeding
Evidence of active urinary tract infection
Diagnosis of a congenital abnormality of
kidneys or urinary tract
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Major bleed requiring blood transfusion
Major bleed requiring intervention
Major bleed requiring nephrectomy
Major bleed leading to mortality
|
Hb estimation at 6-8 hours
USG at 6-8 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haematuria
Haematoma 5 cm
Bleed not requiring blood transfusion/intervention
Various side effects of drug (like hyponatremia) |
at 6-8 hours
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Renal biopsy is associated with bleeding complications like post biopsy hematoma, macroscopic hematuria, etc. - Currently, percutaneous renal biopsy (PRB) is being used, with the aid of ultrasound (US) and spring-loaded biopsy needle in order to decrease the associated complications. - Desmopressin, a synthetic analogue of the ADH hormone, is known to improve functioning of platelets and decrease bleeding occurring because of uremia. - Desmopressin provides a clinical benefit to biopsy patients at risk of complication. |