Perioperative Goal Directed Therapy in Kidney Transplantation

Kidney Transplant; Complications Clinical Trial

Official title:

Perioperative Protocol Goal Directed Therapy in Kidney Transplantation: Fluid Therapy Optimization and Impact on Postoperative Complications.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776396
• Other study ID #: 31/2016/PO
• Status: Completed
• Start date: May 5, 2016
• Est. completion date: January 30, 2018

Study information

• Verified date: December 2018
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 30, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant; Complications
• Postoperative Complications

Locations

Country	Name	City	State
Italy	"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency rate of postoperative complications	The frequency rate of the subsequent postoperative complications in the two study cohort will be determined: early postoperative pulmonary complications (prolonged mechanical ventilation, failure acute respiratory disease, acute pulmonary edema, pulmonary infections); major cardiovascular complications (ischemic cardiac events and heart failure congestive); major surgical complications (anastomosis, delayed postoperative ileum, nausea and postoperative vomiting).	7 days after transplantation
Primary	Duration of hospitalization in a semi-intensive and intensive hospital ward.		7 days after transplantation
Secondary	Number of patients with delayed graft failure in the two study cohorts		7 days after transplantation
Secondary	Number of patients requiring hemodialysis in the two study cohorts		7 days after transplantation