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Completed

NCT Number: NCT03446196

Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.

The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Padova

Padova, Veneto, 35127, Italy

About this study

Renal transplantation is actually considered the optimal elective treatment for end stage kidney disease.

Successful renal transplantation involves the optimization of several parameters. Previous studies have suggested that perioperative hemodynamic factors influence immediate and long-term graft survival.

Perioperative hemodynamic management of this kind of surgery is nowadays focused on optimization of fluid therapy concerning both the donor and the graft and their interaction. Postoperative graft function is not exclusively determined by donor and graft characteristics. Several studies over the last 30 years indeed demonstrated that hemodynamic status of the recipient during kidney transplant surgery relates to graft function and proper management of balancing fluid plays a critical role through maintaining optimal blood volume and so assure an adequate supply of oxygen to the tissues.

Aggressive expansion of the intravascular volume during transplantation surgery has been recommended by most previous studies supporting the so called "liberal" approach to fluid management suggesting that a massive intravascular volume expansion was necessary improve renal blood flow and minimize hypoperfusion caused tissue damages. Nowadays it is clear that adequate early graft function requires perfusion of the transplanted kidney, which may be enhanced by expansion of the intravascular volume in the recipient. However, some studies have reported that aggressive intraoperative volume expansion is not always warranted in kidney transplantation and can expose patients with preexistent cardiac disease or poor myocardial function to the risk of fluid overload, acute respiratory failure, and prolonged ventilation. Moreover fluid overload has been demonstrated to be harmful even for graft perfusion, microcirculation and tissue oxygen delivery.

There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.

The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent Renal transplantation candidate

Exclusion criteria

Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

Treatment and study plan

Fluid replacement based on MOSTCARE up

Device

Clinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12%

Primary outcomes

  1. Urine output in the first hour post unclamping (ml) in the two groups

    Time frame: first hour post unclamping during kydney transplanation

    Urine output in the first hour post unclamping (ml) in the two groups

Secondary outcomes

  1. 1) Urine output in the first 24h (ml)

    Time frame: 24hour

    • Urine output in the first 24h (ml)
  2. 2) Need for haemodialysis in the first week (% of patients)

    Time frame: 7 days

    • Need for haemodialysis in the first week (% of patients)
  3. 3) First week creatinine and urea trend in the two groups

    Time frame: 7 days

    • First week creatinine and urea trend in the two groups

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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