- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07279064
Central Venous Pressure Versus Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients
Comparison of Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Sepsis and septic shock remain among the leading causes of morbidity and mortality in intensive care units worldwide. Septic shock is defined as a subset of sepsis characterized by profound circulatory, cellular, and metabolic dysfunction, associated with a high risk of death despite adequate fluid resuscitation, vasopressor support, and infection source control. The cornerstone of early septic shock management is hemodynamic resuscitation, with intravenous fluids serving as the first-line therapy to restore effective circulating blood volume, improve cardiac output, and optimize tissue perfusion. However, while adequate fluid administration is lifesaving, excessive fluid loading can be detrimental, leading to interstitial edema, impaired oxygen delivery, increased intra-abdominal pressure, and pulmonary edema that may worsen outcomes. Therefore, precise identification of patients who are "fluid responsive" is of paramount clinical importance.
A direct comparison between CVP (as a traditional, static marker) and IVC distensibility index (as a dynamic marker) in patients with septic shock is essential to determine their relative value in guiding fluid resuscitation. This study aims to evaluate and compare the predictive accuracy, feasibility, and clinical applicability of these two parameters as tools for identifying fluid responsiveness in septic shock patients. The results may provide valuable insight into optimizing fluid resuscitation strategies, minimizing fluid overload, and ultimately improving patient outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marwa Abdelmomen Helal
- Phone Number: 01008118263
- Email: marwaamomen@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Adult patients (≥18 years old) both gender. with a clinical diagnosis of septic shock according to Sepsis-3 criteria (persistent hypotension require vasopressors to maintain MAP ≥65 mmHg and serum lactate >2 mmol/L despite adequate fluid resuscitation).(2,3).
- with a central venous catheter in place for CVP monitoring. .awho require fluid resuscitation.
- Exclusion criteria:
.pregnant patients. .Patients with significant right heart failure or severe tricuspid regurgitation (5)..
.Patients with increased intra-abdominal pressure or conditions affecting IVC diameter (9).
.Patients with arrhythmias (e.g., atrial fibrillation) that interfere with preload assessment (6).
.Patients who refuse participation.
- patients with contraindications to cvp (coagulopathy,distortion in anatomy of neck,....)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To compare the accuracy of Central Venous Pressure (CVP) and Inferior Vena Cava Distensibility Index (IVC-DI) in predicting fluid responsiveness in patients with septic shock.
Time Frame: All patients will have the measurements of CVP and IVC_DI on arrival within 30 min before resuscitation and after 60 min of resuscitation
|
All patients will have the measurements of CVP and IVC_DI on arrival within 30 min before resuscitation and after 60 min of resuscitation
|
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
Other Study ID Numbers
- CVP-IVCDI-IN SEPTIC SHOCK
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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