Comparison Between Using Cardiometry and IVC Collapsibility

ConditionSeptic Shock

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorMenoufia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Electrical Cardiometry Monitoring1 intervention

Group B: Inferior Vena Cava Collapsibility Assessment Group1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Two Hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menoufia University

Lead sponsor

Source ClinicalTrials.gov

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