Central Venous Pressure Versus Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients

NCT ID: NCT07279064

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-10-31

Brief Summary

This study aims to compare ultrasound-guided inferior vena cava distensibility index(IVC_DI) assessment with central venous pressure (CVP) monitoring for the detection of hypovolemia in septic shocked patients in the emergency department. The primary objective is to evaluate the diagnostic accuracy and clinical utility of IVC distinsisibility index compared to CVP values in both early and post- resuscitation phases. The study will prospectively enroll septic shocked patients, collect demographic and clinical data, and analyze the correlation between IVC DI and CVP measurements to determine their role in guiding fluid resuscitation and hemodynamic management

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.

Conditions

Central Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound guided inferior vena cava distensibility index

This intervention involves bedside ultrasound measurement of the inferior vena cava (IVC) diameter and calculation of the IVC distensibility index. Assessments will be performed both at initial presentation and after fluid resuscitation in shock patients. The procedure is non-invasive, rapid, and performed according to standardized emergency ultrasound protocols.

Intervention Type: DEVICE

Eligibility Criteria

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,....)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Abdelmomen Helal

Comparison of Central venous pressure and Inferior vena cava distensibility index in assessing fluid responsiveness in septic shocked patients

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marwa Abdelmomen Helal

Role: CONTACT

marwaamomen@gmail.com

01008118263

Other Identifiers

CVP-IVCDI-IN SEPTIC SHOCK

Identifier Type: -

Identifier Source: org_study_id