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Completed

NCT Number: NCT03776396

Perioperative Goal Directed Therapy in Kidney Transplantation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Catania, 95123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency rate of postoperative complications

    Time frame: 7 days after transplantation

    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).

  2. Duration of hospitalization in a semi-intensive and intensive hospital ward.

    Time frame: 7 days after transplantation

Secondary outcomes

  1. Number of patients with delayed graft failure in the two study cohorts

    Time frame: 7 days after transplantation

  2. Number of patients requiring hemodialysis in the two study cohorts

    Time frame: 7 days after transplantation

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2018
Registry last updated
Dec 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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