Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

Not Applicable

Completed

• Conditions: Transplant Dysfunction
• Interventions: Device: Fluid replacement based on MOSTCARE up

• Registration Number: NCT03446196
• Lead Sponsor: University of Padova

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-02-26
• Study Start: 2018-03-10
• Status Verified: 2019-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Written informed consent Renal transplantation candidate

Exclusion Criteria

Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOSTCARE UP	Fluid replacement based on MOSTCARE up	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 Outcome Measures

Name	Time	Method
Urine output in the first hour post unclamping (ml) in the two groups	first hour post unclamping during kydney transplanation	Urine output in the first hour post unclamping (ml) in the two groups

Secondary Outcome Measures

Name	Time	Method
1) Urine output in the first 24h (ml)	24hour	1) Urine output in the first 24h (ml)
2) Need for haemodialysis in the first week (% of patients)	7 days	2) Need for haemodialysis in the first week (% of patients)
3) First week creatinine and urea trend in the two groups	7 days	3) First week creatinine and urea trend in the two groups

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Veneto, Italy