Transplant DysfunctionNCT03446196
Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP
A study testing Fluid replacement based on MOSTCARE up in people with Transplant Dysfunction, run by University of Padova at 1 site in Italy.
Trial summary
There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP. The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transplant Dysfunction
- What is being tested?
- Fluid replacement based on MOSTCARE up
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2018to 1 Jan 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent Renal transplantation candidate
Who cannot join
- Double kidney transplantation Living donor kidney transplantation Hystory of heart failure
Trial locations and contacts
1 site in 1 country.
About this study
There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.
The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.
Read the detailed description
Renal transplantation is actually considered the optimal elective treatment for end stage kidney disease.
Successful renal transplantation involves the optimization of several parameters. Previous studies have suggested that perioperative hemodynamic factors influence immediate and long-term graft survival.
Perioperative hemodynamic management of this kind of surgery is nowadays focused on optimization of fluid therapy concerning both the donor and the graft and their interaction. Postoperative graft function is not exclusively determined by donor and graft characteristics. Several studies over the last 30 years indeed demonstrated that hemodynamic status of the recipient during kidney transplant surgery relates to graft function and proper management of balancing fluid plays a critical role through maintaining optimal blood volume and so assure an adequate supply of oxygen to the tissues.
Aggressive expansion of the intravascular volume during transplantation surgery has been recommended by most previous studies supporting the so called "liberal" approach to fluid management suggesting that a massive intravascular volume expansion was necessary improve renal blood flow and minimize hypoperfusion caused tissue damages. Nowadays it is clear that adequate early graft function requires perfusion of the transplanted kidney, which may be enhanced by expansion of the intravascular volume in the recipient. However, some studies have reported that aggressive intraoperative volume expansion is not always warranted in kidney transplantation and can expose patients with preexistent cardiac disease or poor myocardial function to the risk of fluid overload, acute respiratory failure, and prolonged ventilation. Moreover fluid overload has been demonstrated to be harmful even for graft perfusion, microcirculation and tissue oxygen delivery.
There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.
The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.
- Conditions
- Transplant Dysfunction
- Being tested
- Fluid replacement based on MOSTCARE up
- Keywords
- Transplantation, Fluid Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid replacement based on MOSTCARE upDevice
Clinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12%
| Study group | Role | What they receive |
|---|---|---|
| MOSTCARE UP | Experimental | Clinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12% Receives: Device: Fluid replacement based on MOSTCARE up |
| CLINICIAN EXPERIENCE | No intervention | Fluid replacement will be made based on clinician experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine output in the first hour post unclamping (ml) in the two groups
Urine output in the first hour post unclamping (ml) in the two groups
Measured: first hour post unclamping during kydney transplanation
Secondary outcomes (3)
1) Urine output in the first 24h (ml)
- Urine output in the first 24h (ml)
Measured: 24hour
2) Need for haemodialysis in the first week (% of patients)
- Need for haemodialysis in the first week (% of patients)
Measured: 7 days
3) First week creatinine and urea trend in the two groups
- First week creatinine and urea trend in the two groups
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start10 Mar 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transplant DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult patients with end stage kidney disease undergoing single kidney transplantation from deceased donor. Two arms. One arm will undergo fluid replacement based on mostcare UP information, other arm will undergo fluid replacement based on clinician experience.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446196
- Sponsor's protocol ID
- 4423/AO/18
- Status last verified
- Jan 2019
- First submitted
- 20 Feb 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All datas will be probably shared at the end of the study
Publications
Calixto Fernandes MH, Schricker T, Magder S, Hatzakorzian R. Perioperative fluid management in kidney transplantation: a black box. Crit Care. 2018 Jan 25;22(1):14. doi: 10.1186/s13054-017-1928-2.
PubMed 29368625Schnuelle P, Johannes van der Woude F. Perioperative fluid management in renal transplantation: a narrative review of the literature. Transpl Int. 2006 Dec;19(12):947-59. doi: 10.1111/j.1432-2277.2006.00356.x.
PubMed 17081224Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
PubMed 19602972
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP
- ClinicalTrials.gov ID
- NCT03446196
- Acronym / sponsor ID
- 4423/AO/18
- Conditions
- Transplant Dysfunction
- Keywords
- Transplantation, Fluid Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 26 Feb 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.
There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.
The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.
Detailed description
Renal transplantation is actually considered the optimal elective treatment for end stage kidney disease.
Successful renal transplantation involves the optimization of several parameters. Previous studies have suggested that perioperative hemodynamic factors influence immediate and long-term graft survival.
Perioperative hemodynamic management of this kind of surgery is nowadays focused on optimization of fluid therapy concerning both the donor and the graft and their interaction. Postoperative graft function is not exclusively determined by donor and graft characteristics. Several studies over the last 30 years indeed demonstrated that hemodynamic status of the recipient during kidney transplant surgery relates to graft function and proper management of balancing fluid plays a critical role through maintaining optimal blood volume and so assure an adequate supply of oxygen to the tissues.
Aggressive expansion of the intravascular volume during transplantation surgery has been recommended by most previous studies supporting the so called "liberal" approach to fluid management suggesting that a massive intravascular volume expansion was necessary improve renal blood flow and minimize hypoperfusion caused tissue damages. Nowadays it is clear that adequate early graft function requires perfusion of the transplanted kidney, which may be enhanced by expansion of the intravascular volume in the recipient. However, some studies have reported that aggressive intraoperative volume expansion is not always warranted in kidney transplantation and can expose patients with preexistent cardiac disease or poor myocardial function to the risk of fluid overload, acute respiratory failure, and prolonged ventilation. Moreover fluid overload has been demonstrated to be harmful even for graft perfusion, microcirculation and tissue oxygen delivery.
There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.
The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adult patients with end stage kidney disease undergoing single kidney transplantation from deceased donor. Two arms. One arm will undergo fluid replacement based on mostcare UP information, other arm will undergo fluid replacement based on clinician experience.
| Arm | Type | Receives |
|---|---|---|
| MOSTCARE UP | Experimental | Device: Fluid replacement based on MOSTCARE upClinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12% |
| CLINICIAN EXPERIENCE | No intervention | –Fluid replacement will be made based on clinician experience |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent Renal transplantation candidate
Key exclusion criteria (1 listed)
- Double kidney transplantation Living donor kidney transplantation Hystory of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid replacement based on MOSTCARE upClinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12% | Device | MOSTCARE UP |
Primary outcome
Urine output in the first hour post unclamping (ml) in the two groups
Time frame: first hour post unclamping during kydney transplanation
Urine output in the first hour post unclamping (ml) in the two groups
3 secondary outcomes
1) Urine output in the first 24h (ml)
Time frame: 24hour
2) Need for haemodialysis in the first week (% of patients)
Time frame: 7 days
3) First week creatinine and urea trend in the two groups
Time frame: 7 days
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 3 Jan 2019.
- Background: PubMed 29368625Calixto Fernandes MH, Schricker T, Magder S, Hatzakorzian R. Perioperative fluid management in kidney transplantation: a black box. Crit Care. 2018 Jan 25;22(1):14. doi: 10.1186/s13054-017-1928-2.
- Background: PubMed 17081224Schnuelle P, Johannes van der Woude F. Perioperative fluid management in renal transplantation: a narrative review of the literature. Transpl Int. 2006 Dec;19(12):947-59. doi: 10.1111/j.1432-2277.2006.00356.x.
- Background: PubMed 19602972Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
- Individual participant dataSharing planned: Undecided. All datas will be probably shared at the end of the study
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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?
A study testing Fluid replacement based on MOSTCARE up in people with Transplant Dysfunction, run by University of Padova 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 1 inclusion and 1 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 3 Jan 2019. 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?
Urine output in the first hour post unclamping (ml) in the two groups (time frame: first hour post unclamping during kydney transplanation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446196, which also lists 3 linked publications.
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 3 Jan 2019.