CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
PGDTprocedure
Likely dose
Not stated in record
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Search/NCT05035537
NCT05035537N/ACompleted

Hemodynamic Optimization with Perioperative Gold Directed Therapy (PGDT) in Kidney Transplant

IRCCS Azienda Ospedaliero-Universitaria di Bologna·interventional·Posted Sep 5, 2021·Updated Sep 19, 2024

In Brief

A clinical study evaluating PGDT for Kidney Transplant and Complications. Completed, enrolled 181 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 5, 2021
Enrollment StartJan 1, 2018
Primary CompletionNov 30, 2022
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 4.8 years ago

Interventions

PGDTprocedure

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)