Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

NCT ID: NCT03446196

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-10
• Study Completion Date: 2019-01-01

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.

Conditions

Transplant Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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%

Group Type: EXPERIMENTAL

Fluid replacement based on MOSTCARE up

Intervention Type: 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%

CLINICIAN EXPERIENCE

Fluid replacement will be made based on clinician experience

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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%

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Written informed consent Renal transplantation candidate

Exclusion Criteria

Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Alessandro De Cassai

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Padova

Padua, Veneto, Italy

Countries

Italy

References

Calixto Fernandes MH, Schricker T, Magder S, Hatzakorzian R. Perioperative fluid management in kidney transplantation: a black box. Crit Care. 2018 Jan 25;22(1):14. doi: 10.1186/s13054-017-1928-2.

Reference Type: BACKGROUND

PMID: 29368625 (View on PubMed)

Schnuelle P, Johannes van der Woude F. Perioperative fluid management in renal transplantation: a narrative review of the literature. Transpl Int. 2006 Dec;19(12):947-59. doi: 10.1111/j.1432-2277.2006.00356.x.

Reference Type: BACKGROUND

PMID: 17081224 (View on PubMed)

Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

Reference Type: BACKGROUND

PMID: 19602972 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

4423/AO/18

Identifier Type: -

Identifier Source: org_study_id