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CTRI Number  CTRI/2017/11/010695 [Registered on: 29/11/2017] Trial Registered Prospectively
Last Modified On: 29/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Screening 
Study Design  Single Arm Study 
Public Title of Study   evaluation of fluid therapy in patients undergoing kidney transplantaion surgery by serial ultrasonography echocardiography 
Scientific Title of Study   To find out the role of serial perioperative transthoracic echocardiography and lung ultra-sonographic evaluations as a non-invasive tool for judicious fluid therapy in ESRD patients undergoing kidney transplantation surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kamal kajal 
Designation  Assistant professor 
Affiliation  MD,PDCC 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, FOURTH FLOOR, NEHRU HOSPITAL, POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, FOURTH FLOOR, NEHRU HOSPITAL, POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India 
Phone  1722756500  
Fax  01722756500  
Email  kamal.kajal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  kamal kajal 
Designation  Assistant professor 
Affiliation  MD,PDCC 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, FOURTH FLOOR, NEHRU HOSPITAL, POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, FOURTH FLOOR, NEHRU HOSPITAL, POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India 
Phone  1722756500  
Fax  01722756500  
Email  kamal.kajal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  kamal kajal 
Designation  Assistant professor 
Affiliation  MD,PDCC 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, FOURTH FLOOR, NEHRU HOSPITAL, POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, FOURTH FLOOR, NEHRU HOSPITAL, POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India 
Phone  1722756500  
Fax  01722756500  
Email  kamal.kajal@gmail.com  
 
Source of Monetary or Material Support  
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH 160012 
 
Primary Sponsor  
Name  POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH  
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, 4 FLOOR NEHRU HOSPITAL, PGIMER, SECTOR 12 , CHANDIGARH 160012 
Type of Sponsor  Research institution and hospital 
 
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 Kamal Kajal  POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH   Renal transplant centre,Nehru hospital, ground floor, sector 12,
Chandigarh
CHANDIGARH 
7087009545
1722756500
kamal.kajal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  END STAGE RENAL DISEASE UNDERGOING RENAL TRANSPLANT,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LUNG ULTRASONOGRAPHY AND ECHOCARDIOGRAPHY  To determine the incidence of fluid overload in patients undergoing renal transplantation using Transthoracic echocardiogarphy and lung usg. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for living donor renal transplantation
2. age 18 to 60 years
 
 
ExclusionCriteria 
Details  1. Age under 18 years and more than 60 years
2. pregnant patient
3. cadaveric renal transplant 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
FIND OUT THE INCIDENCE OF FLUID OVERLOAD BY SERIAL LUNG ULTRASOUND AND TRANSTHORACIC ECHOCARDIOGRAPHY  1. BEFORE INDUCTION
2.AT END OF SURGERY
3. POSTOPERATIVE PERIOD 
 
Secondary Outcome  
Outcome  TimePoints 
TO EVALUATE THE EFFECTIVENESS OF HEMODYNAMIC PARAMETERS (CVP,PPV) IN FLUID THERAPY  1. BASELINE
2. EVERY 15 MINS TILL END OF PROCEDURE
3. END OF SURGERY 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   06/12/2017 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Fluid therapy is usually decided peri-operatively on the basis of haemodynamic variables like CVP, mean arterial pressure, urine output and serum lactate values.  Predicting the fluid requirements on the basis of these variables is often unreliable even in the hands of expert anaesthesiologists and intensive care physicians. Moreover,  renal transplantation recipients are often anuric and are on frequent dialysis therapy. Presence of autonomic neuropathy further adds to the complexity for managing these patients. Imprecise monitoring may  lead to iatrogenic catastrophic consequences, such as pulmonary edema due to over-hydration, impairment of pulmonary blood gas exchange, or electrolyte disturbances.

Point-of-care lung ultrasonography has a great potential for guiding the fluid management of critically ill patients.6,7 B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care settings. Literature indicates that B-lines may be used to predict extravascular lung water (EVLW) and pulmonary artery occlusion pressure (PAOP).8, While EVLW is a direct sign of pulmonary congestion, PAOP estimates the pressure in an area that extends from the lung capillaries to the left ventricle and indicates hemodynamic congestion.10 A recent study has shown a tight correlation between absence of B-lines at lung ultrasound and low levels of PAOP.9 However this modality has not been used during renal transplant surgery where judicious fluid management plays a vital role in the early functioning of the graft. Therfore the present study has been planned to assess the utility of perioperative lung ultrasonography in the early detection of volume overload in patients undergoing elective live- related renal transplantation .

 
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