Hypotension During Surgery, Kidney Transplant; Complications
Conditions
Keywords
HPI
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.
Interventions
DEVICEACUMEN (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.
DEVICEInvasive Blood Pressure
Invasive Blood Pressure permits continue monitoring of blood pressure (routine standard for kidney transplant surgery)
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Hospital mortality | First 30 post-operative days after surgery (post-operative) | Number of patient died in the first 30 days after surgery |
| Intensive Care Unit Length of Stay | First 30 post-operative days after surgery (post-operative) | Number of hours of ICU admission |
| 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 | — |
| Post-operative delirium | First 5 post-operative days | CAM-ICU positive (asses one time for a day in the first 5 postoperative days) |
| Hospital Length of Stay | First 30 post-operative days after surgery (post-operative) | Number of days before hospital discharge |
Countries
Italy
Contacts
Primary ContactAntonio Siniscalchi, MD
Backup ContactLorenzo Querci, MD
Outcome results
None listed