Clinical trial NCT03776396: Perioperative Goal Directed Therapy in Kidney Transplantation
Official title: Perioperative Protocol Goal Directed Therapy in Kidney Transplantation: Fluid Therapy Optimization and Impact on Postoperative Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant; Complications
Keywords: Perioperative Goal Directed Therapy
Minimally invasive hemodynamic monitoring
Kidney transplantation
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 33 consecutive patients candidates for kidney transplantation from cadaver that meet the eligibility criteria of the study and 33 patients who underwent kidney transplantation in 2015

Brief summary: In literature there is a huge amount of works demonstrating the direct correlation between volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major postoperative complications in patients with high cardiovascular risk and chronic renal failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that in certain populations with high surgical and post-operative complications risk, the adoption of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The current trend is therefore to guarantee greater precision in the intraoperative management of patients undergoing kidney transplantation from cadaver by using a specific protocol that can be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT), resulting from the adoption of an advanced minimally invasive hemodynamic monitoring technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively tested in an extensive case series of high perioperative risk patients underwent to major abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic surgery. In the present study there will be enrolled all patients who are candidates for kidney transplant from cadaver at the University Hospital "G. Rodolico" of Catania that meet the inclusion criteria of the study and will give their informed consent to participation. The enrolled patients will be monitored for a maximum period of 7 days from transplantation. As control group there will be considered an historical cohort of patients who underwent kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed according to the international guidelines.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Classification III-IV;
* Age between 18 and 65 years;
* First kidney transplantation from cadaver;
* Absence of atrial fibrillation or severe arrhythmia;
* Informed consent.

Exclusion Criteria:

* Lack of informed consent;
* Age less that 18 or greater than 65 years;
* Atrial fibrillation and high frequency tachyarrhythmias;
* Previous transplantation from cadaver.

Primary outcomes:
measure: Frequency rate of postoperative complications
timeFrame: 7 days after transplantation
measure: Duration of hospitalization in a semi-intensive and intensive hospital ward.
timeFrame: 7 days after transplantation
Secondary outcomes:
measure: Number of patients with delayed graft failure in the two study cohorts
timeFrame: 7 days after transplantation
measure: Number of patients requiring hemodialysis in the two study cohorts
timeFrame: 7 days after transplantation
Other outcomes:
Locations:
city: Catania
country: Italy
facility: "G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"
Study officials:
References: