NCT07411469 Comparison Between Using Cardiometry and IVC Collapsibility
| NCT ID | NCT07411469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Menoufia University |
| Condition | Septic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-10 |
| Primary Completion | 2026-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-05-10 with a primary completion date of 2026-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: \- 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.
Contact & Investigator
Noha Abdallah Afify, Professor
STUDY CHAIR
Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University
Frequently Asked Questions
Who can join the NCT07411469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07411469 currently recruiting?
Yes, NCT07411469 is actively recruiting participants. Contact the research team at ahmedm.fared9@gmail.com for enrollment information.
Where is the NCT07411469 trial being conducted?
This trial is being conducted at Shibīn al Kawm, Egypt.
Who is sponsoring the NCT07411469 clinical trial?
NCT07411469 is sponsored by Menoufia University. The principal investigator is Noha Abdallah Afify, Professor at Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University. The trial plans to enroll 60 participants.