Kidney TransplantNEPHRONNCT07912645
ASSISTED FLUID MANAGEMENT SYSTEM IN KIDENY TRANSPLANTATION
A study testing Fluid bolus administration in people with Kidney Transplant, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The NEPHRON study is a prospective, randomized controlled trial evaluating the use of an automated fluid management system during kidney transplantation. A total of 48 adult patients will be randomly assigned to either an Assisted Fluid Management (AFM) group or a standard care group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Fluid bolus administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 yo
Who cannot join
- refuse to consent heart failure with Ejection Fraction< 35% Severe Cardiac Valvular diseases
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Artificial iNtelligEnce for Perioperative Hemodynamic Optimization duRing Kidney transplantatiON: a Randomised Clinical Trial
The NEPHRON study is a prospective, randomized controlled trial evaluating the use of an automated fluid management system during kidney transplantation. A total of 48 adult patients will be randomly assigned to either an Assisted Fluid Management (AFM) group or a standard care group. The primary objective is to compare the total volume of intravenous fluids administered during surgery. Secondary outcomes include intraoperative hypotension, vasopressor requirements, postoperative kidney function, and complications. The study aims to assess whether AFM-guided therapy can optimize intraoperative fluid administration in kidney transplant recipients.
Read the detailed description
Kidney transplantation is a treatment for patients with advanced kidney disease. During surgery, maintaining adequate blood pressure and giving the right amount of intravenous fluids are important to support blood circulation and the function of the transplanted kidney.
Giving too much or too little fluid may lead to complications. New monitoring systems can help anesthesiologists decide when patients may benefit from receiving additional fluids.
The aim of the NEPHRON study is to investigate whether a computer-assisted fluid management system can improve the management of intravenous fluids during kidney transplantation compared with standard care.
This study will include 48 adult patients undergoing kidney transplantation at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy.
Participants will be randomly assigned to one of two groups. In the first group, anesthesiologists will use a computer-assisted system that provides real-time recommendations about fluid administration. In the second group, anesthesiologists will manage fluid administration using standard blood pressure and circulation monitoring parameters.
The main outcome will be the total amount of intravenous fluids administered during surgery.
The researchers will also compare blood pressure changes, the use of medications to support blood pressure, kidney function after transplantation, urine output, and postoperative complications.
The study aims to determine whether computer-assisted fluid management can help anesthesiologists provide more appropriate fluid treatment during kidney transplantation.
- Conditions
- Kidney Transplant
- Being tested
- Fluid bolus administration
- Keywords
- kidney transplantation, hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid bolus administrationDevice
fluid challenge will be performed according to artificial intelligence
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | fluid will be administered based on the assisted fluid management system Receives: Device: Fluid bolus administration |
| control group | No intervention | fluid will be administered based on standard hemodyamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of fluids
Measured: during syrgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912645
- Sponsor's protocol ID
- 23125
- Acronym
- NEPHRON
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial iNtelligEnce for Perioperative Hemodynamic Optimization duRing Kidney transplantatiON: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07912645
- Acronym / sponsor ID
- NEPHRON / 23125
- Conditions
- Kidney Transplant
- Keywords
- kidney transplantation, hemodynamic monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 3 Nov 2026 (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.
The NEPHRON study is a prospective, randomized controlled trial evaluating the use of an automated fluid management system during kidney transplantation. A total of 48 adult patients will be randomly assigned to either an Assisted Fluid Management (AFM) group or a standard care group. The primary objective is to compare the total volume of intravenous fluids administered during surgery. Secondary outcomes include intraoperative hypotension, vasopressor requirements, postoperative kidney function, and complications. The study aims to assess whether AFM-guided therapy can optimize intraoperative fluid administration in kidney transplant recipients.
Detailed description
Kidney transplantation is a treatment for patients with advanced kidney disease. During surgery, maintaining adequate blood pressure and giving the right amount of intravenous fluids are important to support blood circulation and the function of the transplanted kidney.
Giving too much or too little fluid may lead to complications. New monitoring systems can help anesthesiologists decide when patients may benefit from receiving additional fluids.
The aim of the NEPHRON study is to investigate whether a computer-assisted fluid management system can improve the management of intravenous fluids during kidney transplantation compared with standard care.
This study will include 48 adult patients undergoing kidney transplantation at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy.
Participants will be randomly assigned to one of two groups. In the first group, anesthesiologists will use a computer-assisted system that provides real-time recommendations about fluid administration. In the second group, anesthesiologists will manage fluid administration using standard blood pressure and circulation monitoring parameters.
The main outcome will be the total amount of intravenous fluids administered during surgery.
The researchers will also compare blood pressure changes, the use of medications to support blood pressure, kidney function after transplantation, urine output, and postoperative complications.
The study aims to determine whether computer-assisted fluid management can help anesthesiologists provide more appropriate fluid treatment during kidney transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Fluid bolus administrationfluid will be administered based on the assisted fluid management system |
| control group | No intervention | –fluid will be administered based on standard hemodyamic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age > 18 yo
Key exclusion criteria (2 listed)
- refuse to consent heart failure with Ejection Fraction< 35% Severe Cardiac Valvular diseases
- -
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 bolus administrationfluid challenge will be performed according to artificial intelligence | Device | treatment group |
Primary outcome
amount of fluids
Time frame: during syrgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
Related trials for Kidney Transplant
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Hypothermic Kidney Machine Perfusion With Omnisol
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid bolus administration in people with Kidney Transplant, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 2 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact andrea russo, medical doctor (+390630153160, andrea.russo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of fluids (time frame: during syrgery). 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 3 Nov 2026.