Is Dynamic arterial elastance able to predict decrease in vasopressor dose in post operative liver transplant recipients

Recruiting

• Conditions: Hepatic fibrosis,

• Registration Number: CTRI/2023/07/055112
• Lead Sponsor: Mahatma Gandhi Medical College and Hospital

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 measurehemodynamic 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-24
• Last Update Posted: 2023-07-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• •Patient refusal •Concomitant therapy with epinephrine, dobutamine, or dopamine. •Recurrent cardiac arrhythmia •Reduced ventricular systolic function.
• left (ejection fraction <40%).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
-To describe EaDyn variations induced by change in vasopressors dose	-To study variation of hemodynamic parameters induced by change in vasopressors dose

Trial Locations

Locations (1)

Mahatma Gandhi Medical College and Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Mahatma Gandhi Medical College and Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Ganesh Ramaji Nimje

Principal investigator

9503332784

ganesh.nimje8@gmail.com