ClinicalTrials.gg
Not yet recruitingNCT07912645NEPHRONUpdated Nov 3, 2026

ASSISTED FLUID MANAGEMENT SYSTEM IN KIDENY TRANSPLANTATION

An interventional study of Fluid bolus administration in Kidney Transplant, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Kidney Transplant

Keywords

  • kidney transplantation
  • hemodynamic monitoring
03

In context

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

age > 18 yo

Exclusion criteria

Exclusion Criteria:

refuse to consent heart failure with \< 35% Severe Cardiac Valvular diseases

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    treatment group

    fluid will be administered based on the assisted fluid management system

    Device: Fluid bolus administration

  • No intervention
    control group

    fluid will be administered based on standard hemodyamic monitoring

Interventions

  • DeviceFluid bolus administration

    fluid challenge will be performed according to artificial intelligence

06

What researchers measure

Primary outcomes

  1. amount of fluids

    Time frame: during syrgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2029
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07912645
Responsible party
RUSSO ANDREA (DR, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Nov 3, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

andrea russo, medical doctor
Contact
andrea.russo@policlinicogemelli.it
+390630153160

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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