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

NCT07885657 | Not Yet Recruiting

• 1 other identifier: NE prevent AKI in LDLT
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Noradrenaline

Keywords

norepinephrine; acute kidney injury; Living donor liver transplantation

Outcome Measures

Primary Outcomes (1)

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

  Incidence

  within the first 7 days postoperatively

Secondary Outcomes (7)

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

  at 24 then at 72 hours Post-operatively

• Incidence of any norepinephrine specific side effects

  within intraoperative period

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

  intraopeatively

• 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

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

  intraoperatively

Study Arms (2)

Group P (Prophylactic norepinephrine)

ACTIVE COMPARATOR

* 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

Group R (Reactive norepinephrine)

ACTIVE COMPARATOR

* 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

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

Group P (Prophylactic norepinephrine)

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

Group R (Reactive norepinephrine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

President@Mans.Edu.Eg

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will be conducted in a single-blinded fashion. Patients will be blinded to group allocation. The attending anesthesiologist managing intraoperative and early postoperative care will be unblinded to group allocation for patient safety and protocol compliance
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia, Surgical Intensive Care and pain management

Model Details: Patients will be randomly allocated via Computer-generated random sequence using permuted blocks into 2 groups of 42 patients each; Group P (Prophylactic norepinephrine) and Group R (Reactive norepinephrine)

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 21, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

EG (1)