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

Kidney Transplant; Complications Clinical Trial

— HPI2022  

Official title:

Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394896
• Other study ID #: HPI2022
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Antonio Siniscalchi, MD
• Phone: +390512143131
• Email: antonio.siniscalchi[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Surgery
• Kidney Transplant; Complications

Intervention

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.
• Invasive Blood Pressure
Invasive Blood Pressure permits continue monitoring of blood pressure (routine standard for kidney transplant surgery)

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Biancofiore G, Cecconi M, Rocca GD. A web-based Italian survey of current trends, habits and beliefs in hemodynamic monitoring and management. J Clin Monit Comput. 2015 Oct;29(5):635-42. doi: 10.1007/s10877-014-9646-7. Epub 2014 Dec 12. — View Citation

Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gerard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4. — View Citation

Gomez-Izquierdo JC, Feldman LS, Carli F, Baldini G. Meta-analysis of the effect of goal-directed therapy on bowel function after abdominal surgery. Br J Surg. 2015 May;102(6):577-89. doi: 10.1002/bjs.9747. Epub 2015 Mar 11. — View Citation

Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21. — View Citation

Jhanji S, Thomas B, Ely A, Watson D, Hinds CJ, Pearse RM. Mortality and utilisation of critical care resources amongst high-risk surgical patients in a large NHS trust. Anaesthesia. 2008 Jul;63(7):695-700. doi: 10.1111/j.1365-2044.2008.05560.x. Epub 2008 May 16. — View Citation

Lobo SM, Rezende E, Knibel MF, Silva NB, Paramo JA, Nacul FE, Mendes CL, Assuncao M, Costa RC, Grion CC, Pinto SF, Mello PM, Maia MO, Duarte PA, Gutierrez F, Silva JM Jr, Lopes MR, Cordeiro JA, Mellot C. Early determinants of death due to multiple organ failure after noncardiac surgery in high-risk patients. Anesth Analg. 2011 Apr;112(4):877-83. doi: 10.1213/ANE.0b013e3181e2bf8e. Epub 2010 Jun 8. — View Citation

Pearse RM, Harrison DA, James P, Watson D, Hinds C, Rhodes A, Grounds RM, Bennett ED. Identification and characterisation of the high-risk surgical population in the United Kingdom. Crit Care. 2006;10(3):R81. doi: 10.1186/cc4928. Epub 2006 Jun 2. — View Citation

Perilli V, Aceto P, Sacco T, Modesti C, Ciocchetti P, Vitale F, Russo A, Fasano G, Dottorelli A, Sollazzi L. Anaesthesiological strategies to improve outcome in liver transplantation recipients. Eur Rev Med Pharmacol Sci. 2016 Jul;20(15):3172-7. — View Citation

Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291. — View Citation

Walsh SR, Tang T, Bass S, Gaunt ME. Doppler-guided intra-operative fluid management during major abdominal surgery: systematic review and meta-analysis. Int J Clin Pract. 2008 Mar;62(3):466-70. doi: 10.1111/j.1742-1241.2007.01516.x. Epub 2007 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative hypotension time	Hypotension (MAP < 65 mmHg) time relative to the range from 20 minutes after induction to the end of surgery	From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
Secondary	Post-operative hypotension time	Hypotension (MAP < 65 mmHg) time relative to the range from the end of surgery to the first 12 hours after surgery	From the end of surgery to the first 12 hours after surgery (post-operative)
Secondary	Intra-operative severe hypotension time	Severe hypotension (MAP < 50 mmHg) time relative to the range from 20 minutes after induction to the end of surgery	From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
Secondary	Major Adverse Cardiovascular Events (MACE)	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)	First 5 post-operative days after surgery (post-operative)
Secondary	Hospital mortality	Number of patient died in the first 30 days after surgery	First 30 post-operative days after surgery (post-operative)
Secondary	Intensive Care Unit Length of Stay	Number of hours of ICU admission	First 30 post-operative days after surgery (post-operative)
Secondary	Hospital Length of Stay	Number of days before hospital discharge	First 30 post-operative days after surgery (post-operative)
Secondary	Delayed Graft Function (DGF)	Need for hemodialysis in first 7 postoperative days	First 7 post-operative days (post-operative)
Secondary	Graft survival		30 days after transplantation
Secondary	Post-operative delirium	CAM-ICU positive (asses one time for a day in the first 5 postoperative days)	First 5 post-operative days