- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550400
Role of Echocardiography and Ultrasound Indices in Resuscitation of Septic Shock Patients
Echocardiographic Left Ventricular End Diastolic Area Versus Carotid Artery Duplex as a Sensitive Indicator for Guiding Fluid Resuscitation in Septic Shock Patients . A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: baheya kamel
- Phone Number: +2-01115746487
- Email: baheya.hesham.kamel@gmail.com
Study Locations
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Cairo, Egypt
- Recruiting
- Faculty of Medicine, Ain Shams University
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Contact:
- Rania Maher
- Phone Number: +2-01000544520
- Email: raniamhm.rm@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
▪ Age:18-50 years old
- Sex: both males &females.
- Patients diagnosed with septic shock according to SOFA score more than or equal 1
Presence of at least one sign of acute circulatory failure from:
- Low blood pressure (mean arterial pressure <65 mmHg and / or systolic <90 mmHg).
- Tachycardia> 120 bpm without other obvious cause of circulatory failure.
- Oliguria <1 ml / kg during the last hour suggestive of circulatory failure.
- Blood hyperlactatemia > 2mmol / l without other obvious cause a systemic circulatory failure.
- Another sign justifying, for example vascular increase capillary refill time more than 2 seconds.
Exclusion Criteria:
▪ Known significant valvular heart disease (sever aortic insufficiency or stenosis)
- Known carotid artery stenosis >50% or previous carotid surgery
- Clear contraindication to the carotid artery Doppler such as wound or infection or complete or partial occlusion of the carotid artery.
- Arrhythmias affect stroke volume assessment (atrial fibrillation, frequent PVCs)
- Dilated cardiomyopathy.
- Poor transthoracic echocardiographic window
- Patient refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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septic shock patients
septic shock according to SOFA score more than or equal 1
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, Carotid Doppler (T0) will be performed within 1-2 Hours of ICU Admission to measure the following parameters: "Peak systolic velocity" and Velocity Time Integral over the common carotid artery. Using the linear probe (VF12-4) of ultrasound machine (ACUSON NX3, Siemens Medical solution USA, Inc.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of echo and ultrasound indices
Time Frame: 1 Day
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Diagnostic accuracy (sensitivity, specificity) of LVEDA and carotid artery flow parameters (PEAK Systolic Velocity, Velocity time integral (VTI), in predicting fluid responsiveness defined as an increase in stroke volume after a standardized fluid challenge.
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1 Day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD 240L2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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