Which fluid gauge saves more lives? new trial compares heart monitor vs. vein scan in sepsis
NCT ID NCT07411469
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Menoufia University Hospital
RECRUITINGShibīn al Kawm, Menoufia, 23511, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bedside eye scans may reveal hidden blood flow problems in septic shock
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a bedside ultrasound predict which septic shock patients will stop breathing on their own?
- Can a computer model speed up sepsis blood tests?
- A routine calcium reading could reveal how sick a sepsis patient really is