Ultrasound Therapy; ComplicationsNCT03676699
Lung Ultrasound in Detection of Extravascular Lung Water in Septic Patients.
An observational study of Ultrasound Therapy; Complications, run by National Cancer Institute, Egypt at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Ultrasound chest
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2018to 30 Aug 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: All patients meeting the inclusion criteria with severe sepsis and septic shock admitted to the intensive care unit.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, 11796
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Ultrasound chest
- Keywords
- Extravascular lung water, inferior vena cava collapsibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound chestDiagnostic test
Ultrasound detection of extravascular lung water
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 hours follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start30 Mar 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Shaker, MD, Principal investigator, National Cancer Institute- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676699
- Sponsor's protocol ID
- Ehab-Walaa.Ultrasound
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after finishing the submission ,we planned to share the results and conclusion for further benefits.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound as an Evolving Tool in Detection of Extravascular Lung Water in Septic Cancer Patients.
- ClinicalTrials.gov ID
- NCT03676699
- Acronym / sponsor ID
- Ehab-Walaa.Ultrasound
- Conditions
- Ultrasound Therapy; Complications
- Keywords
- Extravascular lung water, inferior vena cava collapsibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the inclusion criteria with severe sepsis and septic shock admitted to the intensive care unit.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound chestUltrasound detection of extravascular lung water | Diagnostic test | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Lung ultrasonography for the assessment of rapid extravascular water variation: evidence from hemodialysis patients.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. after finishing the submission ,we planned to share the results and conclusion for further benefits.
Related trials for Ultrasound Therapy; Complications
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab H Shaker, MD principal investigator
National Cancer Institute- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of B-lines (time frame: 12 hours follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.