| CTRI Number |
CTRI/2024/06/068612 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound guided fluid therapy in mechanically ventilated patients undergoing renal allograft recepient surgery according to central venous pressure and inferior vena cava distensibility index |
|
Scientific Title of Study
|
Correlation between central venous pressure and inferior vena cava distensibility index in mechanically ventilated patients undergoing renal allograft recepient surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Rashmi Jain |
| Designation |
Senior consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Institute of Anaesthesiology
Pain And Perioperative Medicine
SSRB, 5th floor
Sir Ganga Ram Hospital
Central
DELHI
110060
India |
| Phone |
9810645865 |
| Fax |
|
| Email |
write2drrashmi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Maansa Lal |
| Designation |
Resident |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Institute of Anaesthesiology
Pain and Perioperative Medicine
SSRB 5th Floor
Sir Ganga Ram Hospital
Central
DELHI
110060
India |
| Phone |
9999840845 |
| Fax |
|
| Email |
Mansa1srivastava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rashmi Jain |
| Designation |
Senior consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Institute of Anaesthesiology Pain and Perioperative Medicine
SSRB 5th Floor
Sir Ganga Ram Hospital
Central
DELHI
110060
India |
| Phone |
9810645865 |
| Fax |
|
| Email |
write2drrashmi@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SIR GANGA RAM HOSPITAL |
| Address |
INSTITUTE OF ANAESTHESIOLOGY
PAIN AND PERIOPERATIVE MEDICINE
SSRB 5TH FLOOR
SIR GANGA RAM HOSPITAL
DELHI, INDIA
PIN-110060
|
| 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 Sudeep Goyal |
Sir Ganga Ram Hospital |
Institute of Anaesthesiology Pain and Perioperative Medicine
SSRB 5th Floor
Central
DELHI |
9999840845
goyalsudeep13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SIR GANGA RAM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
central venous pressure and usg guided IVC distensibility index measurement |
CVP measurement through Central venous line.
IVC Distensibility index measurement via USG.
Correlate both the indices |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic kidney disease- v
2. ASA 2 and 3 |
|
| ExclusionCriteria |
| Details |
1.non consenting patient
2 Raised abdominal pressure or ascites
3 EF less than 40 percent
4 Heart failure
5 raised intrathoracic pressure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 central venous pressure and 2 inferior vena cava distensibility index
|
1 After induction
2 After declamping
3 Before extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Airway pressure variation with fluid administration
2 prevention of pulmonary oedema |
At the time of fluid administration |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
17/06/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Renal allograft recepient surgeries necessitates proper functioning of the transplanted organ. Fluid administration is a precondition for achieving favourable outcome. Pressure is regularly monitored as a guide to fluid administration. The other techniques used to guide fluid administration are Swan Ganz catheterization and stroke volume variation. This study aims to find a correlation between the point of care ultrasound parameter "inferior vena cava distensibility index and central venous pressure in guiding fluid therapy in mechanically ventilated patients undergoing renal allograft recepient surgery. |