Postoperative ComplicationsNCT07892586
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
A study testing Conventional Fluid Therapy, Low-Dose Norepinephrine and Conservative Goal-Directed Fluid Therapy in people with Postoperative Complications and Pulmonary Complication, run by Assiut University.
Trial summary
This prospective randomized controlled study aims to compare the effect of low-dose norepinephrine combined with conservative goal-directed fluid therapy versus conventional fluid therapy on postoperative pulmonary complications assessed by lung ultrasound score in patients undergoing major hepatobiliary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Pulmonary Complication
- What is being tested?
- Conventional Fluid Therapy, Low-Dose Norepinephrine and Conservative Goal-Directed Fluid Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 20 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older
- Scheduled for elective major hepatobiliary surgery
- ASA physical status I-III
- Written informed consent
Who cannot join
- Emergency surgery
- Pre-existing pulmonary disease
- Preoperative B-lines ≥3 in any lung zone
- Preoperative pulmonary infection or pneumonia
- Compromised heart function (ejection fraction <50%)
- Chronic kidney disease (eGFR <30 mL/min/1.73m²)
- Known allergy or contraindication to study fluids
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Low-Dose Norepinephrine With Conservative Goal-Directed Fluid Therapy on Postoperative Pulmonary Complications in Major Hepatobiliary Surgeries
This prospective randomized controlled study aims to compare the effect of low-dose norepinephrine combined with conservative goal-directed fluid therapy versus conventional fluid therapy on postoperative pulmonary complications assessed by lung ultrasound score in patients undergoing major hepatobiliary surgery.
Read the detailed description
Major hepatobiliary surgery is associated with significant fluid shifts and risk of postoperative pulmonary complications. Lung ultrasound score can quantify loss of lung aeration.
This study will randomize adult patients undergoing elective major hepatobiliary surgery into two groups: one receiving conventional perioperative fluid management and the other receiving low-dose norepinephrine infusion combined with conservative goal-directed fluid therapy. Lung ultrasound score will be assessed at baseline and postoperatively.
- Being tested
- Conventional Fluid Therapy, Low-Dose Norepinephrine, Conservative Goal-Directed Fluid Therapy
- Keywords
- Norepinephrine, Goal-directed fluid therapy, Lung ultrasound, Hepatobiliary surgery, Assiut
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Fluid TherapyOther
Standard perioperative fluid administration based on maintenance requirements, fasting deficit, and third-space losses at 6-8 mL/kg/h using crystalloid solutions.
Low-Dose NorepinephrineDrug
Also called Norepinephrine
Continuous intravenous infusion of norepinephrine starting at 0.03-0.05 µg/kg/min, titrated according to hemodynamic parameters.
Conservative Goal-Directed Fluid TherapyOther
Restricted third-space fluid replacement at 2 mL/kg/h guided by stroke volume variation or pulse pressure variation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Fluid Therapy | Active comparator | Patients will receive conventional perioperative fluid management according to institutional protocol including maintenance fluids, replacement of fasting deficit, and third-space losses at 6-8 mL/kg/h. Receives: Other: Conventional Fluid Therapy |
| Low-Dose Norepinephrine with Conservative Fluid Therapy | Experimental | Patients will receive low-dose norepinephrine infusion at 0.03-0.05 µg/kg/min combined with conservative goal-directed fluid therapy with third-space losses replaced at 2 mL/kg/h. Receives: Drug: Low-Dose Norepinephrine; Other: Conservative Goal-Directed Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung ultrasound score
Mean change in total lung ultrasound score from preoperative baseline to postoperative day 1. Total score is the sum of scores from 12 lung zones (range 0 to 36, higher scores indicate greater loss of lung aeration).
Measured: At postoperative day 1
Secondary outcomes (4)
Lung ultrasound score
Mean total lung ultrasound score (range 0 to 36, higher scores indicate greater loss of lung aeration).
Measured: At postoperative day 3
Number of patients with postoperative pulmonary complications
Number of patients who develop postoperative pulmonary complications within 28 days after surgery.
Measured: At 28 days
Serum creatinine
Mean serum creatinine level in milligrams per deciliter..
Measured: At postoperative day 1
Urine output
Mean urine output in milliliters per kilogram per hour.
Measured: At postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Gamal Maher Mohammed, Assiut University
- Investigators
- Samy A Amr, prof, Study chair, Anesthesia and postsurgical ICU and pain management Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892586
- Sponsor's protocol ID
- Norepi-Fluid-Hepatobiliary-26
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Dose Norepinephrine With Conservative Goal-Directed Fluid Therapy on Postoperative Pulmonary Complications in Major Hepatobiliary Surgeries
- ClinicalTrials.gov ID
- NCT07892586
- Acronym / sponsor ID
- Norepi-Fluid-Hepatobiliary-26
- Keywords
- Norepinephrine, Goal-directed fluid therapy, Lung ultrasound, Hepatobiliary surgery, Assiut
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 23 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.
This prospective randomized controlled study aims to compare the effect of low-dose norepinephrine combined with conservative goal-directed fluid therapy versus conventional fluid therapy on postoperative pulmonary complications assessed by lung ultrasound score in patients undergoing major hepatobiliary surgery.
Detailed description
Major hepatobiliary surgery is associated with significant fluid shifts and risk of postoperative pulmonary complications. Lung ultrasound score can quantify loss of lung aeration.
This study will randomize adult patients undergoing elective major hepatobiliary surgery into two groups: one receiving conventional perioperative fluid management and the other receiving low-dose norepinephrine infusion combined with conservative goal-directed fluid therapy. Lung ultrasound score will be assessed at baseline and postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Fluid Therapy | Active comparator | Other: Conventional Fluid TherapyPatients will receive conventional perioperative fluid management according to institutional protocol including maintenance fluids, replacement of fasting deficit, and third-space losses at 6-8 mL/kg/h. |
| Low-Dose Norepinephrine with Conservative Fluid Therapy | Experimental | Drug: Low-Dose Norepinephrine, Other: Conservative Goal-Directed Fluid TherapyPatients will receive low-dose norepinephrine infusion at 0.03-0.05 µg/kg/min combined with conservative goal-directed fluid therapy with third-space losses replaced at 2 mL/kg/h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Scheduled for elective major hepatobiliary surgery
- ASA physical status I-III
- Written informed consent
Key exclusion criteria (8 listed)
- Emergency surgery
- Pre-existing pulmonary disease
- Preoperative B-lines ≥3 in any lung zone
- Preoperative pulmonary infection or pneumonia
- Compromised heart function (ejection fraction <50%)
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 |
|---|---|---|
| Conventional Fluid TherapyStandard perioperative fluid administration based on maintenance requirements, fasting deficit, and third-space losses at 6-8 mL/kg/h using crystalloid solutions. | Other | Conventional Fluid Therapy |
| Low-Dose NorepinephrineAlso: NorepinephrineContinuous intravenous infusion of norepinephrine starting at 0.03-0.05 µg/kg/min, titrated according to hemodynamic parameters. | Drug | Low-Dose Norepinephrine with Conservative Fluid Therapy |
| Conservative Goal-Directed Fluid TherapyRestricted third-space fluid replacement at 2 mL/kg/h guided by stroke volume variation or pulse pressure variation. | Other | Low-Dose Norepinephrine with Conservative Fluid Therapy |
Primary outcome
Change in lung ultrasound score
Time frame: At postoperative day 1
Mean change in total lung ultrasound score from preoperative baseline to postoperative day 1. Total score is the sum of scores from 12 lung zones (range 0 to 36, higher scores indicate greater loss of lung aeration).
4 secondary outcomes
Lung ultrasound score
Time frame: At postoperative day 3
Number of patients with postoperative pulmonary complications
Time frame: At 28 days
Serum creatinine
Time frame: At postoperative day 1
Urine output
Time frame: At postoperative day 1
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 23 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Samy A Amr, prof study chair
Anesthesia and postsurgical ICU and pain management Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Fluid Therapy, Low-Dose Norepinephrine and Conservative Goal-Directed Fluid Therapy in people with Postoperative Complications and Pulmonary Complication, run by Assiut University.
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 4 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shimaa G Maher, Resident (+20 10 68556675, shimaagamal209@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung ultrasound score (time frame: At postoperative day 1). 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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.