| 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
|
|
|
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
|
|
|
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 .
|