Clinical trial NCT05394896: Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant (HPI2022)
Official title: Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension During Surgery
Kidney Transplant; Complications
Keywords: HPI
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Intra-operative hypotension time
timeFrame: From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
Secondary outcomes:
measure: Post-operative hypotension time
timeFrame: From the end of surgery to the first 12 hours after surgery (post-operative)
measure: Intra-operative severe hypotension time
timeFrame: From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: First 5 post-operative days after surgery (post-operative)
measure: Hospital mortality
timeFrame: First 30 post-operative days after surgery (post-operative)
measure: Intensive Care Unit Length of Stay
timeFrame: First 30 post-operative days after surgery (post-operative)
measure: Hospital Length of Stay
timeFrame: First 30 post-operative days after surgery (post-operative)
measure: Delayed Graft Function (DGF)
timeFrame: First 7 post-operative days (post-operative)
measure: Graft survival
timeFrame: 30 days after transplantation
measure: Post-operative delirium
timeFrame: First 5 post-operative days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
References:
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