Kidney Transplant; ComplicationsNCT03776396
Perioperative Goal Directed Therapy in Kidney Transplantation
An observational study of Kidney Transplant; Complications, run by University of Catania at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant; Complications
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2016to 30 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Lack of informed consent;
- Age less that 18 or greater than 65 years;
- Atrial fibrillation and high frequency tachyarrhythmias;
- Previous transplantation from cadaver.
Trial locations and contacts
1 site in 1 country.
Italy1 site
"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"
Catania, 95123
About this study
Official title: Perioperative Protocol Goal Directed Therapy in Kidney Transplantation: Fluid Therapy Optimization and Impact on Postoperative Complications.
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
- Keywords
- Perioperative Goal Directed Therapy, Minimally invasive hemodynamic monitoring, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days after transplantation
Duration of hospitalization in a semi-intensive and intensive hospital ward.
Measured: 7 days after transplantation
Secondary outcomes (2)
Number of patients with delayed graft failure in the two study cohorts
Measured: 7 days after transplantation
Number of patients requiring hemodialysis in the two study cohorts
Measured: 7 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start5 May 2016
- Primary completion19 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marinella Astuto, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776396
- Sponsor's protocol ID
- 31/2016/PO
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Protocol Goal Directed Therapy in Kidney Transplantation: Fluid Therapy Optimization and Impact on Postoperative Complications.
- ClinicalTrials.gov ID
- NCT03776396
- Acronym / sponsor ID
- 31/2016/PO
- Conditions
- Kidney Transplant; Complications
- Keywords
- Perioperative Goal Directed Therapy, Minimally invasive hemodynamic monitoring, Kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 5 May 2016 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Lack of informed consent;
- Age less that 18 or greater than 65 years;
- Atrial fibrillation and high frequency tachyarrhythmias;
- Previous transplantation from cadaver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Duration of hospitalization in a semi-intensive and intensive hospital ward.
Time frame: 7 days after transplantation
2 secondary outcomes
Number of patients with delayed graft failure in the two study cohorts
Time frame: 7 days after transplantation
Number of patients requiring hemodialysis in the two study cohorts
Time frame: 7 days after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency rate of postoperative complications (time frame: 7 days after transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.