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Not yet recruitingNCT07885657NE AKI in LDLTUpdated Oct 21, 2026

Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation

An interventional study of Norepinephrine started prophylactically immediately post induction of general anesthesia and Norepinephrine infusion will only initiated if mean arterial pressure <65 mmHg despite preload optimization (stroke volume variation <12%) or if systemic vascular resistance <800 dynes•s/cm⁵ in Noradrenaline, sponsored by Mansoura University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

goal-directed fluid therapy has demonstrated benefits on postoperative organ function, vasopressor support with norepinephrine is commonly employed to maintain perfusion pressure, though its renal impact in this setting remains incompletely characterized

Read the detailed description

The aim of this randomized prospective trial is to evaluate whether post-induction prophylactic norepinephrine infusion reduces the incidence of postoperative acute kidney injury (AKI) in adult recipients undergoing living donor liver transplantation, through attenuation of intraoperative hypotension and preservation of renal perfusion

02

Conditions studied

  • Noradrenaline

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Keywords

  • norepinephrine
  • acute kidney injury
  • Living donor liver transplantation
03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 84 is below the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
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

  • Adult patients aged 18-65 years (either sex).
  • Scheduled for elective living donor liver transplantation (LDLT) using a right-lobe graft.
  • Graft-to-recipient weight ratio (GRWR) between 0.8% and 1.4%.
  • Able to understand the study protocol and provide written informed consent.
  • Baseline serum creatinine ≤ 1.4 mg/dL within 1 week prior to surgery

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate or inability to provide informed consent.
  • Acute or fulminant liver failure.
  • Emergency or re-transplantation.
  • Previous upper abdominal surgeries.
  • Pre-existing severe renal dysfunction within 3 months before surgery
  • Hepato-pulmonary syndrome.
  • Moderate to severe cardiac disease
  • Perioperative use of corticosteroids except that used for the fixed immunosuppression protocol
05

Study design

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

Study arms

  • Active comparator
    Group P (Prophylactic norepinephrine)

    * Norepinephrine infusion will not be initiated post induction. * It will only be started if mean arterial pressure \<65 mmHg despite preload optimization (stroke volume variation \<12%) or if Systemic Vascular Resistance\<800 dynes•s/cm⁵. * Starting dose 0.03 - 0.06 μg/kg/min and titrated up to 0.5 μg/kg/min to restore mean arterial pressure ≥65 mmHg

    Drug: Norepinephrine started prophylactically immediately post induction of general anesthesia

  • Active comparator
    Group R (Reactive norepinephrine)

    * Norepinephrine infusion will not be initiated post induction. * It will only be started if mean arterial pressure \<65 mmHg despite preload optimization (stroke volume variation \<12%) or if Systemic Vascular Resistance\<800 dynes•s/cm⁵. * Starting dose 0.03 - 0.06 μg/kg/min and titrated up to 0.5 μg/kg/min to restore mean arterial pressure ≥65 mmHg. * Infusion will be stopped if mean arterial pressure ≥ 65 mmHg and Systemic Vascular Resistancewithin normal range 800-1200 dynes•s/cm⁵

    Drug: Norepinephrine infusion will only initiated if mean arterial pressure <65 mmHg despite preload optimization (stroke volume variation <12%) or if systemic vascular resistance <800 dynes•s/cm⁵

Interventions

  • DrugNorepinephrine started prophylactically immediately post induction of general anesthesia

    Norepinephrine infusion will be started prophylactically immediately post induction at a dose of 0.03 - 0.06 μg/kg/minute as long as mean arterial pressure \< 90 mmHg or systemic vascular resistance\< 1200 dynes•s/cm⁵

  • DrugNorepinephrine infusion will only initiated if mean arterial pressure <65 mmHg despite preload optimization (stroke volume variation <12%) or if systemic vascular resistance <800 dynes•s/cm⁵

    * Norepinephrine infusion will not be initiated post induction. * It will only be started if mean arterial pressure \<65 mmHg despite preload optimization (stroke volume variation \<12%) or if stroke volume variation \<800 dynes•s/cm⁵. * Starting dose 0.03 - 0.06 μg/kg/min and titrated up to 0.5 μg/kg/min to restore mean arterial pressure ≥65 mmHg

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcome (KDIGO) criteria

    Incidence

    Time frame: within the first 7 days postoperatively

Secondary outcomes

  1. Post-operative renal perfusion Assessed by renal resistive index (RRI) measured by ultrasound (US)

    index

    Time frame: at 24 then at 72 hours Post-operatively

  2. Incidence of any norepinephrine specific side effects

    Incidence

    Time frame: within intraoperative period

  3. Total intraoperative fluid volume administered (crystalloids, colloids and blood products)

    milliliter

    Time frame: intraopeatively

  4. Diuretics use and their doses (Furosemide will be administered when clinically indicated for volume overload or persistent oliguria after adequate intravascular volume status has been established)

    mg

    Time frame: intraoperatively and 7 days postoperatively

  5. Incidence and duration of intraoperative hypotension (mean arterial pressure less than 65)

    Incidence

    Time frame: intraoperatively

  6. Serial changes in estimated glomerular filtration rate (eGFR) calculated by the creatinine-based equation at baseline

    mL/min/1.73 m²

    Time frame: postoperative at day 1, 3, 7, 30, and 90

  7. Fibrinogen/Albumin Ratio calculation

    mg/dL

    Time frame: at 24 then at 72 hours Post-operatively

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 239 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 44. This study's planned 24 months is below that.

Counting every sponsor, half of 255 studies reached it within 26 months; a quarter within 12 and three quarters within 44.

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

Registered
Oct 5, 2026
First posted
Oct 21, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Oct 15, 2028
CompletionEst.
Dec 15, 2028
Last update
Oct 21, 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
Oct 21, 2026
Show all 1 update
  1. Oct 21, 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 ↗

09

Registry details

Key details

Study ID
NCT07885657
Responsible party
maha abou-zeid (Professor of Anesthesia, Surgical Intensive Care and pain management, Mansoura University) — Principal investigator
First posted
Oct 21, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Oct 15, 2028 (estimated)
Completion
Dec 15, 2028 (estimated)
Last update
Oct 21, 2026

Oversight

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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