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CTRI Number  CTRI/2019/04/018808 [Registered on: 26/04/2019] Trial Registered Prospectively
Last Modified On: 25/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on effect of oral tolvaptan tablet, which causes free water excretion and increases serum sodium level, to prevent hyponatremia in patients undergoing TURP surgeries. 
Scientific Title of Study   Use of oral Tolvaptan tablet as a pre-medicant to prevent hyponatremia in patients undergoing TURP surgeries: A prospective Comparative study. 
Trial Acronym  Tolvaptan in TURP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr BADRI PRASAD DAS 
Designation  Assistant Professor 
Affiliation  IMS BHU 
Address  Dept of Anaesthesiology and Critical Care IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415214623  
Fax    
Email  badriprasad.dash5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BADRI PRASAD DAS 
Designation  Assistant Professor 
Affiliation  IMS BHU 
Address  Dept of Anaesthesiology and Critical Care IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415214623  
Fax    
Email  badriprasad.dash5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G UMA KANTHAN  
Designation  Junior Resident 
Affiliation  IMS BHU 
Address  Dept of Anaesthesiology and Critical Care IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  7200250135  
Fax    
Email  umakanth1987@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesiology, IMS, BHU, Varanasi 
Dept of Urosurgery, IMS BHU 
 
Primary Sponsor  
Name  Dr Badri Prasad Das 
Address  Assistant Professor, Dept of Anaesthesiology, IMS, BHU, Varanasi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Badri Prasad Das  Sir Suderlal Hospital  Department of Anaesthesiology and Urosurgery, OT number 3 and 4 Institute of Medical Sceinces, Banarus Hindu University , Varanasi
Varanasi
UTTAR PRADESH 		 9415214623

badriprasad.dash5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF MEDICAL SCEINCES,BANARAS HINDU UNIVERSITY,VARANASI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo tablet  Tablet Placebo, as a single oral dose, will be given to eligible patients undergoing TURP surgeries, 3 hours prior to the surgery. 
Intervention  Tablet Tolvaptan 15 mg  Tablet Tolvaptan 15 mg, as a single oral dose, will be given to eligible patients undergoing TURP surgeries, 3 hours prior to the surgery. 
Intervention  Tablet Tolvaptan 30 mg  Tablet Tolvaptan 30 mg (2 tablets of 15 mg each), as a single oral dose, will be given to eligible patients undergoing TURP surgeries, 3 hours prior to the surgery. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. All adult patients aged 50-75 yrs with good functional status with METS>4,with diagnosis of BPH posted for TURP surgery.
2.Prostate size >60 gms.
3.Surgeries done under monopolar cautery ( M-TURP) and irrigation fluid of 1.5% glycine.
4.Baseline serum sodium level less than or equal to 132meq/lit. 
 
ExclusionCriteria 
Details  1.Patients with history of allergy to study drugs.
2.Uncontrolled diabetes mellitus and hypertension
3.H/O Acute MI, any cardiac conditions,EF < 30 %
4.Patients with cerebro vascular diseases, renal diseases and any other endocrine disorders like SIADH causing electrolyte imbalances.
5.C/I for subarachnoid block
7.Prostate surgery lasting less than 30 mins and more than 2 hrs 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Hyponatremia  Serum and Urine samples for sodium and osmolarity values, will be taken at atleast 3 points of time, beforte start of therapy (Baseline), preoperativeley (at 3rd hour of giving the drug) and post-operatively at 1st hour after the patient is brought to Post-Anaesthesia-Care Unit. And at anytime as and when required. 
 
Secondary Outcome  
Outcome  TimePoints 
Any side effects, use of hypertonic saline as a rescue for sympotamatic hyponatremia, cost-effectiveness  Patients will be observed for atleast 2 days post-operatively, or more if required. 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2020 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   http://www.roaic.eg.net/text.asp?2016/3/4/157/195879 http://www.onlinejacc.org/content/63/12_Supplement 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [umakanth1987@gmail.com].

  6. For how long will this data be available start date provided 25-12-2021 and end date provided 25-04-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
This study is a randomised,double blind,parallel group,placebo controlled study comparing the efficacy and safety of oral Tolvaptan tablets 15 mg and 30 mg for 18 months in 84 patients from 26-3-2019 to 30-9-2020 in patients with Benign Hypertrophy of Prostate undergoing TURP surgeries which will be a single centric study in Institute of Medical Sceinces,BHU,Varanasi. The primary outcome will be the incidence of hyponatremia and secondary outcome is to find out any side effects.
 
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