Which fluid gauge saves more lives? new trial compares heart monitor vs. vein scan in sepsis

NCT ID NCT07411469

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 60 people with septic shock, a severe infection that causes dangerously low blood pressure. Doctors need to give fluids carefully, but too much can be harmful. The trial compares two methods—a heart monitor (cardiometry) and an ultrasound of a large vein (IVC collapsibility)—to see which better predicts who needs more fluids. The goal is to help doctors make safer, more personalized treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Menoufia University Hospital

    RECRUITING

    Shibīn al Kawm, Menoufia, 23511, Egypt

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