Clincosm LogoSign in Get a demo

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

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05394896
Collaborator
(none)
46
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ACUMEN (Edwards Lifesciences, Irvine, USA)
  • Device: Invasive Blood Pressure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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)

  4. Hospital mortality [First 30 post-operative days after surgery (post-operative)]

    Number of patient died in the first 30 days after surgery

  5. Intensive Care Unit Length of Stay [First 30 post-operative days after surgery (post-operative)]

    Number of hours of ICU admission

  6. Hospital Length of Stay [First 30 post-operative days after surgery (post-operative)]

    Number of days before hospital discharge

  7. Delayed Graft Function (DGF) [First 7 post-operative days (post-operative)]

    Need for hemodialysis in first 7 postoperative days

  8. Graft survival [30 days after transplantation]

  9. Post-operative delirium [First 5 post-operative days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cristiana Laici, MD, Principal Investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
ClinicalTrials.gov Identifier:
NCT05394896
Other Study ID Numbers:
  • HPI2022
First Posted:
May 27, 2022
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cristiana Laici, MD, Principal Investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
HPI
Additional relevant MeSH terms:
Hypotension

Study Results

No Results Posted as of Jun 23, 2022