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

NCT05394896 | Unknown

• 1 other identifier: HPI2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension During Surgery; Kidney Transplant; Complications

Keywords

HPI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Post-operative hypotension time

  From the end of surgery to the first 12 hours after surgery (post-operative)

• Intra-operative severe hypotension time

  From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)

• Major Adverse Cardiovascular Events (MACE)

  First 5 post-operative days after surgery (post-operative)

• Hospital mortality

  First 30 post-operative days after surgery (post-operative)

• Intensive Care Unit Length of Stay

  First 30 post-operative days after surgery (post-operative)

Study Arms (2)

HPI group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

Conventional therapy according to standard monitoring in the operating room which includes invasive blood pressure monitoring.

Device: Invasive Blood Pressure

Interventions

ACUMEN (Edwards Lifesciences, Irvine, USA) DEVICE

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.

HPI group

Invasive Blood Pressure DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First single or double kidney transplant from a cadaveric donor;
• ASA Class III-IV;
• Signature of informed consent.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40100, Italy

RECRUITING

Related 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.

  PMID: 25500761 BACKGROUND

• 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.

  PMID: 27466988 BACKGROUND

• 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.

  PMID: 21884645 BACKGROUND

• 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.

  PMID: 20530615 BACKGROUND

• 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.

  PMID: 16749940 BACKGROUND

• 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.

  PMID: 18489613 BACKGROUND

• 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.

  PMID: 27004412 BACKGROUND

• 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.

  PMID: 20966436 BACKGROUND

• 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.

  PMID: 25759947 BACKGROUND

• 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.

  PMID: 18031528 BACKGROUND

Central Study Contacts

Antonio Siniscalchi, MD

CONTACT

+390512143131; antonio.siniscalchi@aosp.bo.it

Lorenzo Querci, MD

CONTACT

+393933980223; lorenzo.querci@studio.unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 27, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: January 31, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)