- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03676699
Lung Ultrasound in Detection of Extravascular Lung Water in Septic Patients.
September 18, 2018 updated by: Ehab Hanafy Shaker, National Cancer Institute, Egypt
Lung Ultrasound as an Evolving Tool in Detection of Extravascular Lung Water in Septic Cancer Patients.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.Upon recognition of septic shock, management should start promptly, aiming at effective restoration of the intravascular volume, identification, control of source of infection and starting empiric intravenous antimicrobials.
This is a common problem in critically ill patients especially in presence of sepsis.
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.Recently lung ultrasound evolved as a novel tool for assessment of extravascular lung water (EVLW) and lung congestion.
It is a bed side noninvasive assessment tool.
EVLW accumulation is diagnosed through interpretation of B-Lines which are echoic Vertical, comet-tail-like lines extending from the pleura line to the screen edge without fading .The normal lung pattern of no-echo signal or black lung, changes into black and white pattern with lung congestion, then into white lung pattern with alveolar pulmonary edema .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.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 11796
- Department of Anesthesia and Pain medicine.National Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients meeting the inclusion criteria with severe sepsis and septic shock admitted to the intensive care unit.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of B-lines
Time Frame: 12 hours follow up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ehab H Shaker, MD, National Cancer Institute- Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2018
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Actual)
September 19, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Ehab-Walaa.Ultrasound
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
after finishing the submission ,we planned to share the results and conclusion for further benefits.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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