PGDT in Patients Undergoing Kidney Transplant (PGDT)

September 15, 2024 updated by: Cristiana Laici, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

MATERIAL AND METHODS. This study is a multicentric randomized controlled trial comparing two groups of patients undergoing single or dual kidney transplantation from deceased donors. All patients who will meet eligibility criteria will be randomised, using a computer generated randomization list, to either Group 1 (PGDT, intervention group) where minimally invasive continuous CI monitor (Edwards ClearSight) will be 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 DESIGN. The study protocol will be developed across the intraoperative and postoperative periods. In the intraoperative phase all standard monitored parameters such as EKG, SpO2 (oxygen saturation by pulse oximetry), airway pressure etc. will be the same for both groups. Where ClearSight minimally invasive monitoring will be used (Group 1), hemodynamic optimization goals will be as follows: CI ≥ 2.5 L/min/m2 and the SVV <10%. Sequential interventions used to reach the hemodynamic goals are regulated by a flow-chart provided in the study protocol. In Group 2 conventional static hemodynamic parameters (CVP, IBP) are evaluated to achieve an intraoperative MAP ≥ 70 mmHg with corrective actions (fluids, vasoactive agents) implemented according to the recommendations of good clinical practice and international guidelines. Both groups will receive standard induction immunosuppression according to our centre's practice as well as corticosteroid bolus (or two boluses if a dual kidney transplant was performed) before graft reperfusion. In the postoperative period all patients will be transferred to a dedicated post-surgical intensive care unit. The same standardized fluid therapy regimen will be adopted across both groups. Patient data will be prospectively collected, according to the study protocol, by designated personnel using a digital case report form.

SAMPLE SIZE CALCULATION AND STATISTICAL ANALYSIS. The investigators speculate that in order to detect a minimum reduction in the primary outcome of at least 18%, considering a power of 80% and a type I error of 5%, a total of 200 patients would be needed (100 per group). All results will be summarized in the text as means, unless differently stated each time with measures of variability expressed using mean and standard deviation. When reporting medians, measures of variability will be indicated as interquartile range, minimum value, and maximum value. Difference between population means will be obtained using the 2-sample t test; difference between population proportions will be obtained with the chi-square test and Fisher's exact test. Graft survival will be calculated from the date of kidney transplant to the date of last follow-up evaluation, graft loss, or patient death. P-values below or equal to 0.05 are considered as statistically significant.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60126
        • SOD Anestesia e Rianimazione dei Trapianti e Chirurgia Maggiore, Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - GM Lancisi - G Salesi
      • Torino, Italy, 10126
        • Dipartimento di Anestesia e Rianimazione - Città della salute e della scienza, Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (PGDT)
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
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)
No Intervention: Group 2 (control)
Group 2 (control) managed according to local and international best practice guidelines using standard hemodynamic monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: Through study completion, an average of 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative surgical and medical complications
Time Frame: Through study completion, an average of 6 months
Secondary endpoint was the detection of any significant change in the incidence of postoperative surgical (Clavien-Dindo Classification≥ 3) and medical (pulmonary or cardiovascular) complications
Through study completion, an average of 6 months
Incidence of delayed graft function and graft loss
Time Frame: Through study completion, an average of 6 months
Secondary endpoint was the detection of any significant change in the incidence of delayed graft function and graft loss
Through study completion, an average of 6 months
ICU stay
Time Frame: Through study completion, an average of 6 months
Secondary endpoint was the detection of any significant change in the ICU length of stay
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Antonio Siniscalchi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 29, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PGDT2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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