Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

Sponsor
University of Padova (Other)
Overall Status
Completed
CT.gov ID
NCT03446196
Collaborator
(none)
40
1
2
9.8
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fluid replacement based on MOSTCARE up
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Adult patients with end stage kidney disease undergoing single kidney transplantation from deceased donor. Two arms. One arm will undergo fluid replacement based on mostcare UP information, other arm will undergo fluid replacement based on clinician experience.Adult patients with end stage kidney disease undergoing single kidney transplantation from deceased donor. Two arms. One arm will undergo fluid replacement based on mostcare UP information, other arm will undergo fluid replacement based on clinician experience.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP
Actual Study Start Date :
Mar 10, 2018
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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%

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%

No Intervention: CLINICIAN EXPERIENCE

Fluid replacement will be made based on clinician experience

Outcome Measures

Primary Outcome Measures

  1. 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

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

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

  2. 2) Need for haemodialysis in the first week (% of patients) [7 days]

    2) Need for haemodialysis in the first week (% of patients)

  3. 3) First week creatinine and urea trend in the two groups [7 days]

    3) First week creatinine and urea trend in the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Written informed consent Renal transplantation candidate

Exclusion Criteria:

Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Padova Padova Veneto Italy 35127

Sponsors and Collaborators

  • University of Padova

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Alessandro De Cassai, Medical Doctor, University of Padova
ClinicalTrials.gov Identifier:
NCT03446196
Other Study ID Numbers:
  • 4423/AO/18
First Posted:
Feb 26, 2018
Last Update Posted:
Jan 3, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Alessandro De Cassai, Medical Doctor, University of Padova
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2019