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

NCT07885657 — Not applicable, Not yet recruiting, 84 participants, Mansoura University

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Norepinephrine-Assisted Goal-Directed Fluid Therapy and Acute Kidney Injury Incidence in Living Donor Liver Transplantation: A Randomized Prospective Trial

Registry	NCT07885657, acronym NE AKI in LDLT
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	84 (Estimated)
Sponsor	Mansoura University (Other)
Conditions	Noradrenaline
Interventions	Norepinephrine started prophylactically immediately post induction of general anesthesia, 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 (Drug)
Dates	start 2026-10-15 (estimated), primary completion 2028-10-15 (estimated), completion 2028-12-15 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations	1 site in Egypt

-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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Group P (Prophylactic norepinephrine)	Active comparator	Drug: Norepinephrine started prophylactically immediately post induction of general anesthesia	* 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
Group R (Reactive norepinephrine)	Active comparator	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	* 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

Norepinephrine started prophylactically immediately post induction of general anesthesia (Drug): 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
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 (Drug): * 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

+Outcome measures

Primary outcomes

Incidence of postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcome (KDIGO) criteria [within the first 7 days postoperatively]: Incidence

Secondary outcomes

Post-operative renal perfusion Assessed by renal resistive index (RRI) measured by ultrasound (US) [at 24 then at 72 hours Post-operatively]: index
Incidence of any norepinephrine specific side effects [within intraoperative period]: Incidence
Total intraoperative fluid volume administered (crystalloids, colloids and blood products) [intraopeatively]: milliliter
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) [intraoperatively and 7 days postoperatively]: mg
Incidence and duration of intraoperative hypotension (mean arterial pressure less than 65) [intraoperatively]: Incidence
Serial changes in estimated glomerular filtration rate (eGFR) calculated by the creatinine-based equation at baseline [postoperative at day 1, 3, 7, 30, and 90]: mL/min/1.73 m²
Fibrinogen/Albumin Ratio calculation [at 24 then at 72 hours Post-operatively]: mg/dL

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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:

* 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

+Locations (1)

Facility	City	Country	Status
President@Mans.Edu.Eg	Al Mansurah	Egypt