ClinicalTrials.gg
Not yet recruitingNCT07892586Updated Oct 23, 2026

Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery

An interventional study of Conventional Fluid Therapy and Low-Dose Norepinephrine in Postoperative Complications and Pulmonary Complication, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

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

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Postoperative Complications
  • Pulmonary Complication

Keywords

  • Norepinephrine
  • Goal-directed fluid therapy
  • Lung ultrasound
  • Hepatobiliary surgery
  • Assiut
03

In context

Postoperative Complications

1,267 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.

This study's planned enrollment of 100 is below the median of 117 across 710 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 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 and older
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 years or older
  • Scheduled for elective major hepatobiliary surgery
  • ASA physical status I-III
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Conventional Fluid Therapy

    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.

    Other: Conventional Fluid Therapy

  • Experimental
    Low-Dose Norepinephrine with Conservative Fluid Therapy

    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.

    Drug: Low-Dose Norepinephrine · Other: Conservative Goal-Directed Fluid Therapy

Interventions

  • OtherConventional Fluid Therapy

    Standard perioperative fluid administration based on maintenance requirements, fasting deficit, and third-space losses at 6-8 mL/kg/h using crystalloid solutions.

  • Continuous intravenous infusion of norepinephrine starting at 0.03-0.05 µg/kg/min, titrated according to hemodynamic parameters.

    Also known as: Norepinephrine

  • OtherConservative Goal-Directed Fluid Therapy

    Restricted third-space fluid replacement at 2 mL/kg/h guided by stroke volume variation or pulse pressure variation.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At postoperative day 1

Secondary outcomes

  1. Lung ultrasound score

    Mean total lung ultrasound score (range 0 to 36, higher scores indicate greater loss of lung aeration).

    Time frame: At postoperative day 3

  2. Number of patients with postoperative pulmonary complications

    Number of patients who develop postoperative pulmonary complications within 28 days after surgery.

    Time frame: At 28 days

  3. Serum creatinine

    Mean serum creatinine level in milligrams per deciliter..

    Time frame: At postoperative day 1

  4. Urine output

    Mean urine output in milliliters per kilogram per hour.

    Time frame: At postoperative day 1

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 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 ↗

10

Registry details

Key details

Study ID
NCT07892586
Lead sponsor
Assiut University
Responsible party
Shimaa Gamal Maher Mohammed (Resident Physician, Department of Anesthesia, Assiut University) — Principal investigator
First posted
Oct 23, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Oct 20, 2027 (estimated)
Completion
Feb 20, 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Shimaa G Maher, Resident
Contact
shimaagamal209@gmail.com
+20 10 68556675
Samy A Amr, prof
study chair · Anesthesia and postsurgical ICU and pain management Department, Assiut University Hospitals

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Norepinephrine

Start the discussion