Comparison Between Using Cardiometry and IVC Collapsibility

NCT07411469 | Recruiting DMC

• 1 other identifier: Cardiometry and IVC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Septic shock, a severe form of sepsis, is characterized by persistent hypotension and cellular/metabolic abnormalities despite adequate fluid resuscitation. It is associated with high mortality rates globally, necessitating timely diagnosis and treatment. Fluid resuscitation and vasopressor use are cornerstones of management, but they must be tailored to the individual to prevent complications such as fluid overload.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Septic Shock Evaluation

  Assessment of the participants which suffering from Septic Shock by using Inferior Vena Cava Collapsibility and Electrical Cardiometry for assisting the Fluid Responsiveness

  Two Hours

Study Arms (2)

Electrical Cardiometry Monitoring

Non-invasive assessment of stroke volume and cardiac output using electrical cardiometry at baseline and after fluid challenge.

Procedure: Cardiometry

Inferior Vena Cava Collapsibility Assessment Group

Thirty patients with septic shock will undergo bedside ultrasound assessment of the inferior vena cava to measure the collapsibility index for evaluation of fluid responsiveness. Measurements will be performed as part of routine clinical monitoring without any alteration to standard clinical management.

Procedure: Cardiometry

Interventions

Cardiometry PROCEDURE

Bedside ultrasound measurement of inferior vena cava diameters during the respiratory cycle to calculate the collapsibility index at baseline and after fluid challenge

Also known as: Inferior Vena Cava Ultrasound Assessment

Electrical Cardiometry Monitoring; Inferior Vena Cava Collapsibility Assessment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study protocol approval prior to implementation of the research will be obtained from Faculty of Medicine, Menoufia University Research Ethics Committee. Parents were informed about the study purpose and its consequences, confirming confidentiality of data. A signed informed consent was a pre-requisite for the study. Type of study: Prospective study Site of study: This study will be conducted at the Intensive Care Unit, Faculty of Medicine, Menoufia university Hospital. The study population: The study will include (60) septic Shock patients who admitted to Intensive Care Unit.

You may qualify if:

• Patients Diagnosed with Hypotensive Sepsis: Patients must meet the clinical criteria for sepsis according to the Sepsis-3 definitions, including evidence of infection and hypotension despite adequate fluid resuscitation. Hypotension is defined as systolic blood pressure \<90 mmHg or mean arterial pressure (MAP) \<65 mmHg.
• BMI ≥18.5 and ≤40 kg/m²: Patients will be included regardless of BMI, as long as it falls within the normal to overweight/obese range. Extremes of BMI (e.g., \<18.5 or \>40) may be excluded due to the potential influence on peripheral perfusion measurements.
• American Society of Anesthesiologists (ASA) Physical Status Classification as:
• ASA Score I-III: Patients with an ASA physical status score of I (healthy patients), II (mild systemic disease), or III (severe systemic disease) will be included. Patients with ASA IV or V (those with severe systemic disease that is a constant threat to life) will be excluded due to potential confounding factors.

You may not qualify if:

• \- Cardiac Conditions: Significant valvular heart diseases, such as severe mitral or aortic regurgitation, which can affect hemodynamic assessments.
• Presence of major cardiac arrhythmias, including atrial fibrillation or frequent ectopic beats, as these can interfere with accurate measurement of fluid responsiveness.
• \- Renal Considerations: Patients undergoing renal replacement therapy or those with end-stage renal disease, as fluid balance and responsiveness may be altered.
• Pregnancy Hemodynamic changes during pregnancy (e.g., increased cardiac output and altered vascular resistance) differ significantly from septic shock.
• Patients with a body mass index (BMI) greater than 40 kg/m² Obesity can affect the accuracy of non-invasive monitoring techniques with poor window.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University Hospital

Shibīn al Kawm, Menoufia, 23511, Egypt

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Noha Abdallah Afify, Professor

  Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University

  STUDY CHAIR

Central Study Contacts

Ahmed Mohamed Fared, MSc

CONTACT

+201005305140; ahmedm.fared9@gmail.com

Mohamed Fathy Abdelaziz, Lecturer

CONTACT

+201002209632; Dr_mohamed_fathy251@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anaesthesia, Intensive Care and Pain Management Department

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 13, 2026
• Study Start: May 10, 2025
• Primary Completion: May 10, 2026
• Study Completion: May 20, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-05

Locations

EG (1)