NoradrenalineNE AKI in LDLTNCT07885657
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
A study testing 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 people with Noradrenaline, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Noradrenaline
- What is being tested?
- 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2026to 15 Dec 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
President@Mans.Edu.Eg
Al Mansurah, 35511
Maha Ahmed Abozeid, MD, 00201019216192, mahazed@yahoo.com
Moaaz Mohammed Elsaeed, MSc, 00201018020909, moaaz.mohammed94@gmail.com
About this study
Official title: Norepinephrine-Assisted Goal-Directed Fluid Therapy and Acute Kidney Injury Incidence in Living Donor Liver Transplantation: A Randomized Prospective Trial
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
- Conditions
- Noradrenaline
- Being tested
- 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
- Keywords
- norepinephrine, acute kidney injury, Living donor liver transplantation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine started prophylactically immediately post induction of general anesthesiaDrug
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/cm⁵Drug
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcome (KDIGO) criteria
Incidence
Measured: within the first 7 days postoperatively
Secondary outcomes (7)
Post-operative renal perfusion Assessed by renal resistive index (RRI) measured by ultrasound (US)
index
Measured: at 24 then at 72 hours Post-operatively
Incidence of any norepinephrine specific side effects
Incidence
Measured: within intraoperative period
Total intraoperative fluid volume administered (crystalloids, colloids and blood products)
milliliter
Measured: 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)
mg
Measured: intraoperatively and 7 days postoperatively
Incidence and duration of intraoperative hypotension (mean arterial pressure less than 65)
Incidence
Measured: intraoperatively
Serial changes in estimated glomerular filtration rate (eGFR) calculated by the creatinine-based equation at baseline
mL/min/1.73 m²
Measured: postoperative at day 1, 3, 7, 30, and 90
Fibrinogen/Albumin Ratio calculation
mg/dL
Measured: at 24 then at 72 hours Post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NoradrenalineStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885657
- Sponsor's protocol ID
- NE prevent AKI in LDLT
- Acronym
- NE AKI in LDLT
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine-Assisted Goal-Directed Fluid Therapy and Acute Kidney Injury Incidence in Living Donor Liver Transplantation: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT07885657
- Acronym / sponsor ID
- NE AKI in LDLT / NE prevent AKI in LDLT
- Conditions
- Noradrenaline
- Keywords
- norepinephrine, acute kidney injury, Living donor liver transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 21 Oct 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.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Norepinephrine started prophylactically immediately post induction of general anesthesiaNorepinephrine 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 | Drug | 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* 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 | Drug | Group R (Reactive norepinephrine) |
Primary outcome
Incidence of postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcome (KDIGO) criteria
Time frame: within the first 7 days postoperatively
Incidence
7 secondary outcomes
Post-operative renal perfusion Assessed by renal resistive index (RRI) measured by ultrasound (US)
Time frame: at 24 then at 72 hours Post-operatively
Incidence of any norepinephrine specific side effects
Time frame: within intraoperative period
Total intraoperative fluid volume administered (crystalloids, colloids and blood products)
Time frame: 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)
Time frame: intraoperatively and 7 days postoperatively
Incidence and duration of intraoperative hypotension (mean arterial pressure less than 65)
Time frame: intraoperatively
Serial changes in estimated glomerular filtration rate (eGFR) calculated by the creatinine-based equation at baseline
Time frame: postoperative at day 1, 3, 7, 30, and 90
Fibrinogen/Albumin Ratio calculation
Time frame: at 24 then at 72 hours Post-operatively
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 21 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Noradrenaline, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 8 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative acute kidney injury defined according to the Kidney Disease Improving Global Outcome (KDIGO) criteria (time frame: within the first 7 days postoperatively). 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 21 Oct 2026.