NCT07892586

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Feb 2028

First Submitted

Initial submission to the registry

October 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2028

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 18, 2026

Last Update Submit

October 18, 2026

Conditions

Postoperative ComplicationsPulmonary Complication

Keywords

NorepinephrineGoal-directed fluid therapyLung ultrasoundHepatobiliary surgeryAssiut

Outcome Measures

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).

    At postoperative day 1

Secondary Outcomes (4)

  • Lung ultrasound score

    At postoperative day 3

  • Number of patients with postoperative pulmonary complications

    At 28 days

  • Serum creatinine

    At postoperative day 1

  • Urine output

    At postoperative day 1

Study Arms (2)

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.

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.

Drug: Low-Dose NorepinephrineOther: Conservative Goal-Directed Fluid Therapy

Interventions

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.

Conventional Fluid Therapy
Low-Dose NorepinephrineDRUG

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

Also known as: Norepinephrine
Low-Dose Norepinephrine with Conservative Fluid Therapy
Conservative Goal-Directed Fluid TherapyOTHER

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

Low-Dose Norepinephrine with Conservative Fluid Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 years or older
  • Scheduled for elective major hepatobiliary surgery
  • ASA physical status I-III
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Samy A Amr, prof

    Anesthesia and postsurgical ICU and pain management Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Shimaa G Maher, Resident

CONTACT

+20 10 68556675shimaagamal209@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Anesthesia

Study Record Dates

First Submitted

October 18, 2026

First Posted

October 23, 2026

Study Start

October 20, 2026

Primary Completion (Estimated)

October 20, 2027

Study Completion (Estimated)

February 20, 2028

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share