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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Hypotension During Surgery; Kidney Transplant; Complications

Treatments: Device: ACUMEN (Edwards Lifesciences, Irvine, USA); Device: Invasive Blood Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT05394896

HPI2022

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

HPI group

Experimental group

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.

Treatment:

Device: ACUMEN (Edwards Lifesciences, Irvine, USA)

Control group

Active Comparator group

Description:

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

Treatment:

Device: Invasive Blood Pressure