Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

NCT03446196 | Completed

• 1 other identifier: 4423/AO/18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Dysfunction

Keywords

Transplantation, Fluid Balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  24hour

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

  7 days

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

  7 days

Study Arms (2)

MOSTCARE UP

EXPERIMENTAL

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 EXPERIENCE

NO INTERVENTION

Fluid replacement will be made based on clinician experience

Interventions

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%

MOSTCARE UP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent Renal transplantation candidate

You may not qualify if:

• Double kidney transplantation Living donor kidney transplantation Hystory of heart failure

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padova

Padua, Veneto, 35127, Italy

Location

Related 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.

  PMID: 29368625 BACKGROUND

• 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.

  PMID: 17081224 BACKGROUND

• 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.

  PMID: 19602972 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: March 10, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

IT (1)