Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant (HPI2022)

Study Overview
=================
Brief Summary
-----------------
HPI monitoring and the adoption of therapeutic interventions before hypotension occurs should be ensure a shorter time of intra-operative hypotension (MAP < 65 mmHg) during deceased-donor kidney transplant surgery. The control group is represented by patients undergoing the same surgical procedure with hemodynamic monitoring with invasive blood pressure monitoring which represents the gold standard for this surgery. HPI monitoring has not yet been investigated during this surgery.

Official Title
-----------------
Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT

Conditions
-----------------
Hypotension During Surgery, Kidney Transplant; Complications

Intervention / Treatment
-----------------
* Device: ACUMEN (Edwards Lifesciences, Irvine, USA)
* Device: Invasive Blood Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First single or double kidney transplant from a cadaveric donor; ASA Class III-IV; Signature of informed consent. Exclusion Criteria: Patient with atrial fibrillation rhythm or high frequency tachyarrhythmias; Severe valvulopathies; Combined single/double kidney-liver-transplant; Patients in whom the need for monitoring would still be expected advanced, invasive or minimally invasive hemodynamic, regardless of the allocation to the study group; Inclusion in another study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPI group<br>Conventional therapy and monitoring with ACUMEN sensor (Edwards Lifesciences, Irvine, USA) and Hemosphere platform (Edwards Lifesciences, Irvine, USA) of invasive blood pressure. Strategy to prevent hypotension based on HPI index, Eadyn and dP/dTmax. | Device: ACUMEN (Edwards Lifesciences, Irvine, USA)<br>* ACUMEN sensor generates HPI index which should predict hypotension. Based on HPI index, Eadyn and dP/dTmax values anaesthesia should somministrate liquid or drugs to prevent hypotension.<br>|
| Active Comparator: Control group<br>Conventional therapy according to standard monitoring in the operating room which includes invasive blood pressure monitoring. | Device: Invasive Blood Pressure<br>* Invasive Blood Pressure permits continue monitoring of blood pressure (routine standard for kidney transplant surgery)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative hypotension time | Hypotension (MAP < 65 mmHg) time relative to the range from 20 minutes after induction to the end of surgery | From 20 minutes after anaesthesia induction to the end of surgery (intra-operative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hypotension time | Hypotension (MAP < 65 mmHg) time relative to the range from the end of surgery to the first 12 hours after surgery | From the end of surgery to the first 12 hours after surgery (post-operative) | 
| Intra-operative severe hypotension time | Severe hypotension (MAP < 50 mmHg) time relative to the range from 20 minutes after induction to the end of surgery | From 20 minutes after anaesthesia induction to the end of surgery (intra-operative) | 
| Major Adverse Cardiovascular Events (MACE) | Number of major cardiovascular complications (MACE) within the first five days after kidney transplantation (for MACE the composite endpoint of heart attack is considered heart failure, heart failure or presumed cardiac death) | First 5 post-operative days after surgery (post-operative) | 
| Hospital mortality | Number of patient died in the first 30 days after surgery | First 30 post-operative days after surgery (post-operative) | 
| Intensive Care Unit Length of Stay | Number of hours of ICU admission | First 30 post-operative days after surgery (post-operative) | 
| Hospital Length of Stay | Number of days before hospital discharge | First 30 post-operative days after surgery (post-operative) | 
| Delayed Graft Function (DGF) | Need for hemodialysis in first 7 postoperative days | First 7 post-operative days (post-operative) | 
| Graft survival |  | 30 days after transplantation | 
| Post-operative delirium | CAM-ICU positive (asses one time for a day in the first 5 postoperative days) | First 5 post-operative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPI