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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676699
Other study ID # Ehab-Walaa.Ultrasound
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 30, 2018
Est. completion date August 30, 2018

Study information

Verified date September 2018
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Ultrasound Therapy; Complications

Intervention

Diagnostic Test:
Ultrasound chest
Ultrasound detection of extravascular lung water

Locations

Country Name City State
Egypt Department of Anesthesia and Pain medicine.National Cancer Institute Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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