Lung Ultrasound in Detection of Extravascular Lung Water in Septic Patients.

• ClinicalTrials.gov Identifier: NCT03676699
• Recruitment Status: Completed
• First Posted: September 19, 2018
• Last Update Posted: September 19, 2018
• Sponsor: National Cancer Institute, Egypt
• Information provided by (Responsible Party): Ehab Hanafy Shaker, National Cancer Institute, Egypt

Study Description

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.

Condition or disease	Intervention/treatment
Ultrasound Therapy; Complications	Diagnostic Test: Ultrasound chest

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Official Title: Lung Ultrasound as an Evolving Tool in Detection of Extravascular Lung Water in Septic Cancer Patients.
• Actual Study Start Date: March 30, 2018
• Actual Primary Completion Date: August 30, 2018
• Actual Study Completion Date: August 30, 2018

Groups and Cohorts

Intervention Details:

• Diagnostic Test: Ultrasound chest
  Ultrasound detection of extravascular lung water

Outcome Measures

Primary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes 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.

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.

Contacts and Locations

Locations

Egypt

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, Egypt, 11796

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

• Principal Investigator: Ehab H Shaker, MD; National Cancer Institute- Cairo University

More Information

Additional Information:

Lung ultrasonography for the assessment of rapid extravascular water variation: evidence from hemodialysis patients. 

• Responsible Party: Ehab Hanafy Shaker, lecturer of anesthesia ,critical care and pain medicine, National Cancer Institute, Egypt
• ClinicalTrials.gov Identifier: NCT03676699
• Other Study ID Numbers: Ehab-Walaa.Ultrasound
• First Posted: September 19, 2018
• Last Update Posted: September 19, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: after finishing the submission ,we planned to share the results and conclusion for further benefits.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ehab Hanafy Shaker, National Cancer Institute, Egypt:

Extravascular lung water, inferior vena cava collapsibility