NCT03429751

Brief Summary

Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 5, 2018

Last Update Submit

February 9, 2018

Conditions

Fluid Overload

Keywords

lung ultrasound, fluid, hysterectomy, B lines

Outcome Measures

Primary Outcomes (1)

  • The rate of lung ultrasound B lines appearance.

    Three or more comet lines appearance in a lung field. Two or more positive regions per side suggested a B-pattern. B -lines are defined as discrete laser-like vertical hyper-echoic artifacts that arise from the pleura line extend to the bottom of the screen without fading and move synchronously with lung sliding.

    5 minutes after the end of surgery.

Secondary Outcomes (14)

  • The total volume of crystalloid infusion.

    Intraoperative.

  • The total volume of blood transfusion.

    Intraoperative.

  • The amount of blood loss.

    Intraoperative.

  • The duration of surgery.

    intraoperative.

  • Central venous pressure

    Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.

  • +9 more secondary outcomes

Study Arms (2)

Liberal fluid group

EXPERIMENTAL

received 30 ml/Kg/h crystalloid for maximum 3 hours.

Drug: 30 ml/Kg/h crystalloid

Restrictive fluid group

ACTIVE COMPARATOR

received 10 ml /Kg/h crystalloids for maximum 3 hours.

Drug: 10 ml/Kg/h crystalloid

Interventions

30 ml/Kg/h crystalloidDRUG

Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.

Liberal fluid group
10 ml/Kg/h crystalloidDRUG

Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.

Restrictive fluid group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometrial carcinoma patients scheduled for an abdominal hysterectomy.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients scheduled for an elective laparoscopic hysterectomy.
  • American society of anesthesiologists status I-II.

You may not qualify if:

  • Patient refusal.
  • Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months).
  • Valvular heart diseases.
  • Renal insufficiency (GFR\<60 ml/kg/1.73m2).
  • Hepatic insufficiency (Albumin less than 3).
  • Patient with previous or current history of pulmonary disease.
  • History of allergy to anesthetic drugs.
  • Obese patients (BMI\>30).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Center Mansoura University.

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Edema

Interventions

Crystalloid Solutions

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor of anesthesia and surgical intensive care

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

July 10, 2016

Primary Completion

July 10, 2017

Study Completion

September 1, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

EG(1)