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

Not Applicable

Recruiting

• Conditions: Kidney Transplant; Complications; Hypotension During Surgery
• Interventions: Device: Invasive Blood Pressure; Device: ACUMEN (Edwards Lifesciences, Irvine, USA)

• Registration Number: NCT05394896
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-05-27
• Study Start: 2022-11-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-11-30
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Invasive Blood Pressure	Conventional therapy according to standard monitoring in the operating room which includes invasive blood pressure monitoring.
HPI group	ACUMEN (Edwards Lifesciences, Irvine, USA)	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.

Primary Outcome Measures

Name	Time	Method
Intra-operative hypotension time	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

Secondary Outcome Measures

Name	Time	Method
Intra-operative severe hypotension time	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
Major Adverse Cardiovascular Events (MACE)	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)
Intensive Care Unit Length of Stay	First 30 post-operative days after surgery (post-operative)	Number of hours of ICU admission
Hospital mortality	First 30 post-operative days after surgery (post-operative)	Number of patient died in the first 30 days after surgery
Hospital Length of Stay	First 30 post-operative days after surgery (post-operative)	Number of days before hospital discharge
Post-operative delirium	First 5 post-operative days	CAM-ICU positive (asses one time for a day in the first 5 postoperative days)
Post-operative hypotension time	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
Delayed Graft Function (DGF)	First 7 post-operative days (post-operative)	Need for hemodialysis in first 7 postoperative days
Graft survival	30 days after transplantation

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy