NCT03676699

Brief Summary

Sepsis is a common serious problem in surgical critical care units.Septic shock can be a consequence of severe sepsis with high mortality rate, in which there is major disturbance on the cellular, metabolic and circulatory levels.Patients who suffer from malignancy or under chemotherapeutic treatment are at higher risk of sepsis.Postoperative cancer patients carry both the risk of underlying malignancy with superimposed risk of major surgical procedure.\]. Monitoring effective fluid resuscitation and patient's hemodynamic status is achieved through different techniques mainly by measuring central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP) and transpulmonary thermodilution along with chest radiography analysis .This study aims to investigate the correlation between lung ultrasound and IVC collapsibility index in assessment of fluid responsiveness in cancer patients with septic shock.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

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

March 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

September 17, 2018

Last Update Submit

September 18, 2018

Conditions

Keywords

Extravascular lung water, inferior vena cava collapsibility

Outcome Measures

Primary Outcomes (1)

  • Detection of B-lines

    The number of B lines was scanned and a quadrant was considered to be positive when 3 or more B-Lines were recorded. A patient was defined to have positive B-lines (when 3 or more B-Lines are recorded in 3 or more quadrants).

    12 hours follow up

Interventions

Ultrasound chestDIAGNOSTIC_TEST

Ultrasound detection of extravascular lung water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients meeting the inclusion criteria with severe sepsis and septic shock admitted to the intensive care unit.

You may qualify if:

  • Patients aged between (18 - 65) years.
  • Diagnosed with severe sepsis or septic shock according to the third international consensus definition (sepsis-3).
  • All of them underwent major abdominal oncologic surgeries.

You may not qualify if:

  • ASA III and IV patients.
  • Patients with BMI\>35.
  • Patients who suffered from chronic lung disease.
  • History of cardiac or renal problems.
  • Patients with lung cancer or pulmonary metastases.
  • Patients with inserted chest tubes.
  • Presence of subcutaneous emphysema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

Study Officials

  • Ehab H Shaker, MD

    National Cancer Institute- Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia ,critical care and pain medicine

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

March 30, 2018

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations