| CTRI Number |
CTRI/2024/12/078465 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to predict postoperative complications in liver transplant recipients by applying non-invasive NIRS electrodes over forehead and limbs intraoperatively to observe Cerebral and Somatic Oxygen Saturation, and compare them. |
|
Scientific Title of Study
|
Intraoperative Cerebral and Somatic Oxygen Saturation Monitoring as Predictors of Postoperative Complications in Liver transplantation : An observational 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 |
Dr Heena Saghavi |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences, New Delhi |
| Address |
Department of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi.
South
DELHI
110070
India |
| Phone |
7798630238 |
| Fax |
|
| Email |
heenasanghavi2504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences, New Delhi |
| Address |
Department of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi.
South
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences, New Delhi |
| Address |
Department of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi.
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Institute of Liver and Biliary Sciences, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Institue of Liver and Biliary Sciences. |
| Address |
Department of Anaesthesiology, phase 2, 3rd floor, Institute of Liver and Biliary Sciences, New Delhi |
| 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 Heena Sanghavi |
Institute of Liver and Biliary Sciences, New Delhi |
Department of Anaesthesiology, 3rd floor, phase 2, Institute of Liver and Biliary Sciences, New Delhi
South
DELHI |
7798630238
heenasanghavi2504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Institute of Liver and Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cirrhotic patients,
Living donor liver transplantation |
|
| ExclusionCriteria |
| Details |
Acute Liver Failure.
Preoperative Hepatorenal Syndrome or Acute Kindney Injury.
Pre-existing Chronic Renal Failure.
Redo Transplant surgery for graft failure.
Diseased Donor Liver Transplantation.
Patient refusal. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Cerebral and Somatic (either arm or thigh) oxygen desaturation using NIRS during Liver transplant surgery to predict postoperative complications. |
From start of surgery to postoperative day 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of AKI and associated risk factors.
Correlating intraoperative cerebral and somatic oxygen desaturation with postoperative Sr. Creatinine, Sr. Cystatin C and Urine (Neutrophil Gelatinase Associated Lipocalin)NGAL levels.
Correlating intraoperative cerebral and somatic oxygen desaturation with postoperative Doppler derived Renal resistive index.
Correlating intraoperative cerebral and somatic (arm and thigh) oxygen desaturation for predicting postoperative cognitive dysfunction and Delirium.
Correlating intraoperative cerebral and somatic (arm and thigh) oxygen desaturation for predicting postoperative Respiratory complications.
Correlating intraoperative cerebral and somatic (arm and thigh) oxygen desaturation for predicting postoperative Cardiovascular complications. |
From start of surgery to postoperative day 7. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/01/2025 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Patients undergoing Liver transplant surgery will be taken in operating room. Standard monitors will be attached. NIRS electrode will be applied to over forehead and same side forearm and thigh. Baseline values will be
recorded after signal stabilization. General Anaesthesia will be given as per
institutional protocol. Cerebral and somatic NIRS data will be collected every 10 mins starting from start of surgery to the end of surgery. NIRS values at all the events of surgery will be
noted- after induction, after dissection phase, anhepatic phase (at the time of IVC
clamping), reperfusion phase, 1 hour after reperfusion phase. A 20% fall in saturation
values will be considered as significant hypoperfusion.
Correction will be given to maintain MAP >70mmHg, Hb >7gm/dl and PaO2
>100mmHg.
The intraoperative monitoring will include operation time, requirement for a
norepinephrine infusion, averages of the hemodynamic parameters (systolic and
diastolic blood pressure, heart rate, and central venous pressure), blood loss, blood
product requirements (packed red blood cells, fresh frozen plasma, single donor
platelets, and cryoprecipitate transfusions), laboratory data (hemoglobin and lactate),
hourly urine output.
Postoperatively, Cystatin C and Urine NGAL will be sent at 48 hours, Sr. Creatinine
levels will be sent for 7 days, Renal resistive index and Confusion assessment method CAM-ICU will be seen for 7 days. Post-operative respiratory insufficiency will be seen in the form of postextubation hypoxemia, reintubation, acute respiratory failure, pulmonary edema,
pneumonia, and atelectasis. Cardiovascular complications will be seen in the form of- arrhythmia, heart failure,
myocardial infarction, cardiac arrest, thromboembolism, and/or stroke. |