Perioperative Goal Directed Therapy in Kidney Transplantation

NCT ID: NCT03776396

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-05
• Study Completion Date: 2018-01-30

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.

Conditions

Kidney Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental cohort

33 patient undergoing to kidney transplantation from cadaver at University Hospital "G. Rodolico" of Catania, in which an innovative Perioperative Goal Directed Therapy (PGDT) protocol will be used.

No interventions assigned to this group

Historical control group

33 patients underwent to kidney transplantation from cadaver at University Hospital "G. Rodolico" of Catania 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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

Marinella Astuto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"

Catania, , Italy

Countries

Italy

Other Identifiers

31/2016/PO

Identifier Type: -

Identifier Source: org_study_id