| CTRI Number |
CTRI/2023/01/048812 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can desmopressin reduce bleeding complication with impaired renal function |
|
Scientific Title of Study
|
Study of The effect of Desmopressin in Reducing Post Kidney Biopsy Bleeding Complications in Patients with Reduced Renal Function |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJESH JHORAWAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Nephrology Department, AIIMS Jodhpur |
| Address |
ASSOCIATE PROFESSOR
NEPHROLOGY DEPARTMENT
AIIMS JODHPUR,
BASNI PHASE 2, JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9461626614 |
| Fax |
|
| Email |
jhorawat2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJESH JHORAWAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Nephrology Department, AIIMS Jodhpur |
| Address |
ASSOCIATE PROFESSOR
NEPHROLOGY DEPARTMENT
AIIMS JODHPUR,
BASNI PHASE 2, JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9461626614 |
| Fax |
|
| Email |
jhorawat2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uttayan Chakrabarti |
| Designation |
Senior Resident |
| Affiliation |
Nephrology Department, AIIMS Jodhpur |
| Address |
NEPHROLOGY DEPARTMENT
AIIMS JODHPUR,
BASNI PHASE 2, JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9461626614 |
| Fax |
|
| Email |
uttayanchakrabarti@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Basni Phase II, Jodhpur (Rajasthan) |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
AIIMS JODHPUR
JODHPUR, RAJASTHAN |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RAJESH JHORAWAT |
AIIMS JODHPUR |
Room No-542 NEPHROLOGY DEPARTMENT
AIIMS JODHPUR
RAJASTHAN
Jodhpur
RAJASTHAN |
9461626614
jhorawat2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N059||Unspecified nephritic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DESMOPRESSIN |
INTRANASAL DESMOPRESSIN (3MICROGM/KG) 1 HR BEFORE KIDNEY BIOPSY |
| Comparator Agent |
Normal saline |
INTRANASAL NORMAL SALINE 1HR BEFORE KIDNEY BIOPSY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
eGFR LESS THAN OR EQUAL TO 60ML/MIN
PLATELET COUNT >1LACK
NORMAL COAGULATION PROFILE
BP<140/90 |
|
| ExclusionCriteria |
| Details |
SOLITARY KIDNEY
RENAL CELL CARCINOMA
HYDRO/PYONEPHROSIS
CONTRATED KIDNEY BILATERAL
MORBID OBESITY >40KG/M2
POST RENAL TRANSPLANT
SEVERSE NASAL CONGESTION,BLOCKAGE,ATROPHIC RHINITIS
SERUM SODIUM<125mEq/L |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INCIDENCE OF POST KIDNEY BIOPSY BLEEDING COMPLICATION (perirenal hematoma, gross hematuria, AV fistula formation, Blood transfusion, arterial embolization or death) |
at 6 hrs and 24 hrs post biopsy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PREDICTOR OF BLEEDING COMPLICATION |
AT 24 HR POST PROCEDURE |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/01/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Desmopressin has been used to decreased the post biopsy bleeding complication. One RCT in patient with normal renal function has shown that desmopressin had reduced post kidney biopsy bleeding complication in normal functioning kidney. However, there is no prospective trial of desmopression on patient with reduced renal function. Hence we design this study to study the impact of desmopressin in reducing bleeding complication post kidney biopsy in patients with reduced renal function. |