| CTRI Number |
CTRI/2023/07/055112 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Is Dynamic arterial elastance able to predict decrease in vasopressor dose in post operative liver transplant recipients |
|
Scientific Title of Study
|
Role of dynamic arterial elastance to predict decrease in mean arterial pressure after reduction of vasopressor in post operative liver transplant recipients |
| 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 Ganesh Ramaji Nimje |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Department of Organ Transplant Anaesthesia and Critical care, Room No - 05 , second floor, Mahatma Gandhi Medical College and Hospital, Sitapura Jaipur
RICCO Industrial Area, Sitapura,
Jaipur
RAJASTHAN
302022
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Ramaji Nimje |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Department of Organ Transplant Anaesthesia and Critical care, Room No - 05 , second floor, Mahatma Gandhi Medical College and Hospital, Sitapura Jaipur
RICCO Industrial Area, Sitapura,
Jaipur
RAJASTHAN
302022
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Ramaji Nimje |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Department of Organ Transplant Anaesthesia and Critical care, Room No - 05 , second floor, Mahatma Gandhi Medical College and Hospital, Sitapura Jaipur
RICCO Industrial Area, Sitapura,
Jaipur
RAJASTHAN
302022
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Hospital and Medical College, Jaipur
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Organ Transplant Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan |
| Type of Sponsor |
Private medical college |
|
|
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 Ganesh Ramaji Nimje |
Mahatma Gandhi Medical College and Hospital |
Department of Organ Transplant Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur
Jaipur
RAJASTHAN |
9503332784
ganesh.nimje8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee , Mahatma Gandhi Medical College and Hospital |
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 |
MOT APPLICABLE |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. PatientS with written informed consent
2. Patients of chronic liver disease undergoing liver transplantation are admitted to the liver transplant ICU on the ongoing infusion of norepinephrine.
3.Age group of 18-60 years
|
|
| ExclusionCriteria |
| Details |
• Patient refusal
•Concomitant therapy with epinephrine, dobutamine, or dopamine.
•Recurrent cardiac arrhythmia
•Reduced ventricular systolic function - left (ejection fraction <40%)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether EaDyn is able to predict a decrease in MAP of more than 10% after reduction of norepinephrine dose in a cohort of postoperative liver transplant recipients. |
-baseline
-15 mins after reduction of norepinephrine
-30 mins after reduction of norepinephrine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To describe EaDyn variations induced by change in vasopressors dose
-To study variation of hemodynamic parameters induced by change in vasopressors dose
|
-baseline
-15 mins after reduction of norepinephrine
-30 mins after reduction of norepinephrine |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/07/2023 |
| 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="6"
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
|
Because of the pathophysiological changes in end-stage liver disease and the complex nature of the liver transplant recipient surgical procedure, the intraoperative course may be associated with coagulopathy, major blood loss, low systemic vascular resistance, and risk of reperfusion syndrome, which may result in hemodynamical instability. As a result, the majority of patients shifted to the intensive care unit (ICU) are on high vasopressor support. In ICU to maintain hemodynamic stability & vital organ perfusion, vasopressors are titrated to maintain mean arterial pressure of greater than 65 mm of Hg. Once hemodynamic stability is achieved, early de-escalation of vasopressor therapy should be considered in order to avoid negative side effects. Some authors have suggested a de-escalation strategy based on the value of dynamic arterial elastance (EaDyn), i.e., the ratio of pulse pressure variation (PPV) over stroke volume variation (SVV): according to these studies, EaDyn could potentially act as a dynamic indicator of arterial tone, useful to enhance a functional approach to vasoactive therapy management. This study is designed to assess whether EaDyn, measured by minimally invasive hemodynamic monitor HemoSphere, is able to predict a decrease in MAP of more than 10% after a reduction of norepinephrine dose in post liver transplant patients admitted to ICU.
Study Protocol The weaning protocol started when the patient becomes hemodynamically stable, and MAP >70-75 mmHg for more than 30 mins and in the absence of any arrhythmia. Norepinephrine dose is to be decreased by 0.03 mcg/kg/min steps according to our ICU protocol. On HemoSphere monitoring system, we will measure hemodynamic parameters such as Heart rate (HR), systolic (SP), diastolic (DP) and mean (MAP) arterial pressure, SV, cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), PPV, SVV and EaDyn before norepinephrine dose reduction (T0) when the patient is hemodynamically stable and another after 30 mins(T30). Parameters at T0 will be considered baseline parameters. The ventilatory setting, level of sedation, and rate of fluid administration will be left unchanged throughout the observational period. The responder will be defined as a decrease of MAP ≥ 10% after norepinephrine dose reduction from baseline and the nonresponder will be defined as a decrease of MAP < 10% after norepinephrine reduction from baseline at T30. Only the hemodynamic data obtained from the first vasopressor dose reduction to each enrolled patient will be used for the analysis. For the safety of the patient, the interruption of the protocol will be at the discretion of the ICU team. |