| CTRI Number |
CTRI/2024/02/062452 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare NICOM vs Invasive monitoring method for blood loss in liver donor surgeries |
|
Scientific Title of Study
|
The feasibility of non-invasive cardiac output monitoring in living donor right hepatectomy – A prospective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopa M N |
| Designation |
Senior Specialist |
| Affiliation |
Aster CMI hospital |
| Address |
Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.
Bangalore Rural KARNATAKA 560092 India |
| Phone |
9886523983 |
| Fax |
|
| Email |
dr.mnroopa@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Roopa M N |
| Designation |
Senior Specialist |
| Affiliation |
Aster CMI hospital |
| Address |
Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.
Bangalore Rural KARNATAKA 560092 India |
| Phone |
9886523983 |
| Fax |
|
| Email |
dr.mnroopa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Roopa M N |
| Designation |
Senior Specialist |
| Affiliation |
Aster CMI hospital |
| Address |
Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.
Bangalore Rural KARNATAKA 560092 India |
| Phone |
9886523983 |
| Fax |
|
| Email |
dr.mnroopa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aster Intramural Research funding. Aster CMI Hospital. Bangalore 560092 |
|
|
Primary Sponsor
|
| Name |
Roopa M N |
| Address |
Aster CMI Hospital |
| Type of Sponsor |
Other [Intramural funding] |
|
|
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 Roopa M N |
Operation theatre, 2nd floor |
Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore. Bangalore KARNATAKA |
9886523983
dr.mnroopa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster - Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Organ transplant - Living donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arterial line, Central line |
Fluid administered to target a CVP ≤ 5, PPV 5-10%. Through out the surgery. Intraoperative period. |
| Intervention |
NICOM device |
Fluid administered to target a CVP ≤ 5, PPV 5-10%. Through out the surgery. Intraoperative. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Living donor hepatectomy surgeries |
|
| ExclusionCriteria |
| Details |
Refusal to participate. Left lobe hepatectomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess fluid administration. |
Perioperatively. At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess blood loss & blood product administration. To assess lactate, kidney function & hemodynamic stability. |
Perioperatively. At the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
15/02/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.mnroopa@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Living donor liver transplantation (LDLT) is an
established treatment modality for end-stage liver disease and it alleviates
the shortage of cadaveric donor organs. Donor safety during the perioperative
period is a major concern of LDLT. In general, hepatectomy causes a
significant blood loss which is among the major causes of post-operative
morbidity and mortality. Any
strategy to reduce blood loss during hepatectomy is important and various
surgical and anaesthetic methods have been reported. Although low central venous pressure technique can
still be effective, it may not be advantageous concerning the safety of healthy
donors undergoing hepatectomy. Emerging evidence suggests that stroke volume
variation, a simple and useful index for fluid responsiveness and preload
status in various clinical situations, can be applied as a guide for fluid
management to reduce blood loss during living donor hepatectomy. Most
hemodynamic monitors used widely now are invasive, which may cause
complications and bring discomfort to the patients. NICOM is an application of
biological reactor technology, monitoring cardiac output, cardiac index, stroke
volume, stroke volume variability and other hemodynamic parameters by analysing
electric pulses through the frequency change of chest. |