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Search / Trial NCT04934943

"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"

Launched by HUMANITAS CLINICAL AND RESEARCH CENTER · Jun 20, 2021

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Fluid Challenge Functional Hemodynamic Test

ClinConnect Summary

This clinical trial is studying a quick test called the "mini fluid challenge" that helps doctors understand how well a patient’s heart responds to receiving a small amount of fluid. This is especially important for patients who are very sick with conditions like sepsis or shock, where blood pressure and blood flow can be dangerously low. During the test, a small amount of fluid (100 ml) is given quickly, and doctors use special machines to measure how the heart’s pumping changes. The study aims to compare three different tools used to measure these changes and see which one gives the most reliable results.

People who might be eligible for this trial are adults aged 65 to 74 who have signs of acute circulatory failure, meaning their blood pressure is low or they need medications to support it, along with symptoms like fast heartbeat, low urine output, or high levels of a blood marker called lactate. Participants can expect to have this mini fluid test done while being closely monitored with these machines. It’s important to note that people with certain heart problems, irregular heartbeats, severe lung issues, or those already on dialysis won’t be able to join. This study is not yet recruiting but aims to help improve how doctors decide on giving fluids to very sick patients, potentially leading to better care.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • 1) Acute circulatory failure defined as:
  • SAP ≤ 90 mmHg (or a decrease \> 50 mm Hg in hypertensive patients)
  • or a mean arterial pressure (MAP) ≤ 70 mmHg
  • or the use of vasopressors to maintain SAP \>90 mmHg,
  • associated with skin mottling; tachycardia ≥100 beats/min; urinary flow ≤0.5 mL/kg for at least 2 hours; blood lactate level ≥4 mmol/L.
  • Exclusion criteria:
  • known severe myocardial or valvular dysfunction
  • cardiac arrhythmias
  • severe acute respiratory distress syndrome
  • on-going haemodialysis or continuous hemofiltration
  • moribund patients
  • persistent low quality of the arterial signal affecting hemodynamic monitoring measurements
  • poor echographic windows.

About Humanitas Clinical And Research Center

Humanitas Clinical and Research Center is a leading institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Located in Italy, the center specializes in conducting high-quality clinical trials across various therapeutic areas, including oncology, cardiology, and neurology. With a commitment to scientific excellence and ethical standards, Humanitas collaborates with academic institutions, pharmaceutical companies, and healthcare organizations to foster groundbreaking discoveries and improve patient outcomes. The center's multidisciplinary team of experts leverages state-of-the-art facilities and cutting-edge technologies to ensure rigorous study design and execution, ultimately contributing to the advancement of medical knowledge and the development of new therapies.

Locations

Rozzano, Milano, Italy

Novara, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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