Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

Transplant Dysfunction Clinical Trial

Official title:

Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446196
• Other study ID #: 4423/AO/18
• Status: Completed
• Phase: N/A
• Start date: March 10, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2019
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Written informed consent Renal transplantation candidate

Exclusion Criteria:

Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

Related Conditions & MeSH terms

• Transplant Dysfunction

Intervention

Device:
• 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%

Locations

Country	Name	City	State
Italy	University of Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine output in the first hour post unclamping (ml) in the two groups	Urine output in the first hour post unclamping (ml) in the two groups	first hour post unclamping during kydney transplanation
Secondary	1) Urine output in the first 24h (ml)	1) Urine output in the first 24h (ml)	24hour
Secondary	2) Need for haemodialysis in the first week (% of patients)	2) Need for haemodialysis in the first week (% of patients)	7 days
Secondary	3) First week creatinine and urea trend in the two groups	3) First week creatinine and urea trend in the two groups	7 days