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

January 13, 2023 updated by: Cristiana Laici, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40100
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPI group
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)
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.
Active Comparator: Control group
Conventional therapy according to standard monitoring in the operating room which includes invasive blood pressure monitoring.
Device: Invasive Blood Pressure
Invasive Blood Pressure permits continue monitoring of blood pressure (routine standard for kidney transplant surgery)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative hypotension time
Time Frame: From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
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
Time Frame: From the end of surgery to the first 12 hours after surgery (post-operative)
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
Time Frame: From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
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)
Time Frame: First 5 post-operative days after surgery (post-operative)
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
Time Frame: First 30 post-operative days after surgery (post-operative)
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
Time Frame: First 30 post-operative days after surgery (post-operative)
Number of hours of ICU admission
First 30 post-operative days after surgery (post-operative)
Hospital Length of Stay
Time Frame: First 30 post-operative days after surgery (post-operative)
Number of days before hospital discharge
First 30 post-operative days after surgery (post-operative)
Delayed Graft Function (DGF)
Time Frame: First 7 post-operative days (post-operative)
Need for hemodialysis in first 7 postoperative days
First 7 post-operative days (post-operative)
Graft survival
Time Frame: 30 days after transplantation
30 days after transplantation
Post-operative delirium
Time Frame: First 5 post-operative days
CAM-ICU positive (asses one time for a day in the first 5 postoperative days)
First 5 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPI2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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