Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypotension During Surgery
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Intra-operative hypotension time
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Cristiana Laici, MD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.
Outcomes
Primary Outcomes
Intra-operative hypotension time
Time Frame: 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 Outcomes
- Intensive Care Unit Length of Stay(First 30 post-operative days after surgery (post-operative))
- Major Adverse Cardiovascular Events (MACE)(First 5 post-operative days after surgery (post-operative))
- Intra-operative severe hypotension time(From 20 minutes after anaesthesia induction to the end of surgery (intra-operative))
- Hospital mortality(First 30 post-operative days after surgery (post-operative))
- Hospital Length of Stay(First 30 post-operative days after surgery (post-operative))
- Post-operative delirium(First 5 post-operative days)
- Post-operative hypotension time(From the end of surgery to the first 12 hours after surgery (post-operative))
- Delayed Graft Function (DGF)(First 7 post-operative days (post-operative))
- Graft survival(30 days after transplantation)