Clinical trial NCT03676699: Lung Ultrasound in Detection of Extravascular Lung Water in Septic Patients.
Official title: Lung Ultrasound as an Evolving Tool in Detection of Extravascular Lung Water in Septic Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Therapy; Complications
Keywords: Extravascular lung water, inferior vena cava collapsibility
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of B-lines
timeFrame: 12 hours follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia and Pain medicine.National Cancer Institute
Study officials:
affiliation: National Cancer Institute- Cairo University
name: Ehab H Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References: