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

Primary Purpose

Hypotension During Surgery, Kidney Transplant; Complications

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

ACUMEN (Edwards Lifesciences, Irvine, USA)

Invasive Blood Pressure

About this trial

This is an interventional treatment trial for Hypotension During Surgery focused on measuring HPI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HPI group

Control group

Arm Description

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.

Conventional therapy according to standard monitoring in the operating room which includes invasive blood pressure monitoring.

Outcomes

Primary Outcome Measures

Intra-operative hypotension time

Hypotension (MAP < 65 mmHg) time relative to the range from 20 minutes after induction to the end of surgery

Secondary Outcome Measures

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

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

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)

Hospital mortality

Number of patient died in the first 30 days after surgery

Intensive Care Unit Length of Stay

Number of hours of ICU admission

Hospital Length of Stay

Number of days before hospital discharge

Delayed Graft Function (DGF)

Need for hemodialysis in first 7 postoperative days

Graft survival

Post-operative delirium

CAM-ICU positive (asses one time for a day in the first 5 postoperative days)

Full Information

NCT ID

NCT05394896

First Posted

May 22, 2022

Last Updated

January 13, 2023

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT05394896

Brief Title

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

Acronym

HPI2022

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension During Surgery, Kidney Transplant; Complications

Keywords

HPI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HPI group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Conventional therapy according to standard monitoring in the operating room which includes invasive blood pressure monitoring.

Intervention Type

Device

Intervention Name(s)

ACUMEN (Edwards Lifesciences, Irvine, USA)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Invasive Blood Pressure

Intervention Description

Invasive Blood Pressure permits continue monitoring of blood pressure (routine standard for kidney transplant surgery)

Primary Outcome Measure Information:

Title

Intra-operative hypotension time

Description

Hypotension (MAP < 65 mmHg) time relative to the range from 20 minutes after induction to the end of surgery

Time Frame

From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)

Secondary Outcome Measure Information:

Title

Post-operative hypotension time

Description

Hypotension (MAP < 65 mmHg) time relative to the range from the end of surgery to the first 12 hours after surgery

Time Frame

From the end of surgery to the first 12 hours after surgery (post-operative)

Title

Intra-operative severe hypotension time

Description

Severe hypotension (MAP < 50 mmHg) time relative to the range from 20 minutes after induction to the end of surgery

Time Frame

From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)

Title

Major Adverse Cardiovascular Events (MACE)

Description

Time Frame

First 5 post-operative days after surgery (post-operative)

Title

Hospital mortality

Description

Number of patient died in the first 30 days after surgery

Time Frame

First 30 post-operative days after surgery (post-operative)

Title

Intensive Care Unit Length of Stay

Description

Number of hours of ICU admission

Time Frame

First 30 post-operative days after surgery (post-operative)

Title

Hospital Length of Stay

Description

Number of days before hospital discharge

Time Frame

First 30 post-operative days after surgery (post-operative)

Title

Delayed Graft Function (DGF)

Description

Need for hemodialysis in first 7 postoperative days

Time Frame

First 7 post-operative days (post-operative)

Title

Graft survival

Time Frame

30 days after transplantation

Title

Post-operative delirium

Description

CAM-ICU positive (asses one time for a day in the first 5 postoperative days)

Time Frame

First 5 post-operative days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antonio Siniscalchi, MD

Phone

+390512143131

antonio.siniscalchi@aosp.bo.it

First Name & Middle Initial & Last Name or Official Title & Degree

Lorenzo Querci, MD

Phone

+393933980223

lorenzo.querci@studio.unibo.it

Facility Information:

Facility Name

IRCCS Azienda Ospedaliero-Universitaria di Bologna

City

Bologna

ZIP/Postal Code

40100

Country

Italy

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25500761

Citation

Biancofiore G, Cecconi M, Rocca GD. A web-based Italian survey of current trends, habits and beliefs in hemodynamic monitoring and management. J Clin Monit Comput. 2015 Oct;29(5):635-42. doi: 10.1007/s10877-014-9646-7. Epub 2014 Dec 12.

Results Reference

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PubMed Identifier

27466988

Citation

Perilli V, Aceto P, Sacco T, Modesti C, Ciocchetti P, Vitale F, Russo A, Fasano G, Dottorelli A, Sollazzi L. Anaesthesiological strategies to improve outcome in liver transplantation recipients. Eur Rev Med Pharmacol Sci. 2016 Jul;20(15):3172-7.

Results Reference

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PubMed Identifier

21884645

Citation

Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291.

Results Reference

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PubMed Identifier

20530615

Citation

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Results Reference

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PubMed Identifier

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Citation

Pearse RM, Harrison DA, James P, Watson D, Hinds C, Rhodes A, Grounds RM, Bennett ED. Identification and characterisation of the high-risk surgical population in the United Kingdom. Crit Care. 2006;10(3):R81. doi: 10.1186/cc4928. Epub 2006 Jun 2.

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PubMed Identifier

18489613

Citation

Jhanji S, Thomas B, Ely A, Watson D, Hinds CJ, Pearse RM. Mortality and utilisation of critical care resources amongst high-risk surgical patients in a large NHS trust. Anaesthesia. 2008 Jul;63(7):695-700. doi: 10.1111/j.1365-2044.2008.05560.x. Epub 2008 May 16.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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

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