PGDT in Patients Undergoing Kidney Transplant

NCT05035537 | Completed DMC

• 1 other identifier: PGDT2017
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multicentric randomized controlled trial comparing two groups of patients undergoing single or dual kidney transplantation from deceased donors. To reduce perioperative complications optimal fluid management is essential in patients undergoing kidney transplantation. Heart rate, Medium Arterial Pressure (MAP), Central Venous Pressure (CVP), and urine output have been proposed in the literature to guide perioperative fluid therapy. These criteria are routinely applied in clinical practice; however these criteria have shown low sensitivity and poor predictive of postoperative complication, especially if used alone. The traditional approach in renal transplantation is the volume infusion guided whit CVP to the point of no further fluid responsiveness, but this can lead to excess fluid which can damage the endothelial glycocalyx and lead to organ failure for a fluid shift into the interstitial space. As a way to reduce postoperative complications in surgical patients, in recent years, several studies have examined Perioperative Goal Directed Therapy (PGDT) as fluid administration guided by optimization of preload with the use of algorithms based on fluids, inotropes and/or vasopressors to achieve a certain goal in stroke volume (SV), cardiac index (CI), or oxygen delivery (DO2). However results regarding the potential role of PGDT cannot be considered definitive, because the various studies on the subject have not all conformed to the same methods and have not uniformly applied the same measurements, so their results regarding the potential role of PGDT cannot be considered definitive. The aim of this work is to compare the effects of PGDT with conventional fluid therapy in patients undergoing kidney transplantation achievable through implementation of the non invasive monitoring.

Conditions

Kidney Transplant; Complications

Keywords

Perioperative Goal Directed Therapy; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  The primary study outcome was to investigate whether the adoption of a PGDT protocol would reduce overall hospital stay.

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• Incidence of postoperative surgical and medical complications

  Through study completion, an average of 6 months

• Incidence of delayed graft function and graft loss

  Through study completion, an average of 6 months

• ICU stay

  Through study completion, an average of 6 months

Study Arms (2)

Group 1 (PGDT)

EXPERIMENTAL

Group 1(PGDT, intervention group) where minimally invasive continuous CI monitor (Edwards ClearSight) was used to guide a goal directed fluid administration protocol

Procedure: PGDT

Group 2 (control)

NO INTERVENTION

Group 2 (control) managed according to local and international best practice guidelines using standard hemodynamic monitoring

Interventions

PGDT PROCEDURE

The minimally invasive continuous CI monitor (Edwards ClearSight) was used to guide an optimization of preload with the use of algorithms based on fluids, inotropes and/or vasopressors to achieve a certain goal in medium arterial pressure (MAP), cardiac index (CI) and stroke volume variation (SVV)

Group 1 (PGDT)

Eligibility Criteria

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

You may qualify if:

• age \> 18 years,
• first single- or dual-kidney transplant from a deceased donor,
• absence of atrial fibrillation or other severe arrythmia,
• ASA (American Society of Anesthesiologists) class III-IV,
• presence of written expression of consent.

You may not qualify if:

• patients receiving a retransplant,
• patients receiving a combined liver-kidney transplant,
• patients receiving a transplant from a living donor .

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

SOD Anestesia e Rianimazione dei Trapianti e Chirurgia Maggiore, Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi

Ancona, Ancona, 60126, Italy

Location

Dipartimento di Anestesia e Rianimazione - Città della salute e della scienza, Torino

Torino, Torino, 10126, Italy

Location

Related Publications (15)

• 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.

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• 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

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  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

• Ameloot K, Palmers PJ, Malbrain ML. The accuracy of noninvasive cardiac output and pressure measurements with finger cuff: a concise review. Curr Opin Crit Care. 2015 Jun;21(3):232-9. doi: 10.1097/MCC.0000000000000198.

  PMID: 25922896 BACKGROUND

• Scolletta S, Franchi F, Romagnoli S, Carla R, Donati A, Fabbri LP, Forfori F, Alonso-Inigo JM, Laviola S, Mangani V, Maj G, Martinelli G, Mirabella L, Morelli A, Persona P, Payen D; Pulse wave analysis Cardiac Output validation (PulseCOval) Group. Comparison Between Doppler-Echocardiography and Uncalibrated Pulse Contour Method for Cardiac Output Measurement: A Multicenter Observational Study. Crit Care Med. 2016 Jul;44(7):1370-9. doi: 10.1097/CCM.0000000000001663.

  PMID: 27097293 BACKGROUND

• Sangkum L, Liu GL, Yu L, Yan H, Kaye AD, Liu H. Minimally invasive or noninvasive cardiac output measurement: an update. J Anesth. 2016 Jun;30(3):461-80. doi: 10.1007/s00540-016-2154-9. Epub 2016 Mar 9.

  PMID: 26961819 BACKGROUND

• van der Spoel AG, Voogel AJ, Folkers A, Boer C, Bouwman RA. Comparison of noninvasive continuous arterial waveform analysis (Nexfin) with transthoracic Doppler echocardiography for monitoring of cardiac output. J Clin Anesth. 2012 Jun;24(4):304-9. doi: 10.1016/j.jclinane.2011.09.008.

  PMID: 22608585 BACKGROUND

• Stover JF, Stocker R, Lenherr R, Neff TA, Cottini SR, Zoller B, Bechir M. Noninvasive cardiac output and blood pressure monitoring cannot replace an invasive monitoring system in critically ill patients. BMC Anesthesiol. 2009 Oct 12;9:6. doi: 10.1186/1471-2253-9-6.

  PMID: 19821993 BACKGROUND

Study Officials

• Antonio Siniscalchi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients (individual participants) are prevented from having knowledge of the interventions assigned
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients who met eligibility criteria were randomised, using a computer generated randomization list, to either Group 1 (PGDT, intervention group) where minimally invasive continuous CI monitor (Edwards ClearSight) was used to guide a goal directed fluid administration protocol, and Group 2 (control) managed according to local and international best practice guidelines using standard hemodynamic monitoring.

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 5, 2021
• Study Start: January 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)