Mini bolus fluid challenge for assessing responsiveness in emergency patients

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

This study is testing if a small amount of fluid given to emergency patients can help doctors figure out who really needs more fluids to feel better during a crisis.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Monastir (Academic / other)
• Locations: 2 sites (Monastir and 1 other locations)
• Trial ID: NCT05369559 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a mini-bolus fluid challenge of 50 ml in predicting fluid responsiveness in spontaneously breathing patients experiencing hemodynamic instability due to acute circulatory failure. The approach involves assessing patients' responses to a passive leg raising technique followed by the fluid challenge to determine their need for further volume expansion. The goal is to avoid unnecessary fluid overload, which can lead to increased morbidity and mortality in critically ill patients. By accurately identifying those who will benefit from fluid therapy, the study aims to improve patient outcomes in emergency settings.

Who should consider this trial

Good fit: Ideal candidates include spontaneously breathing patients with acute circulatory failure and signs of inadequate tissue perfusion.

Not a fit: Patients who are in cardiac arrest, have acute respiratory distress syndrome, or are moribund may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more precise fluid management in critically ill patients, reducing the risk of fluid overload and associated complications.

How similar studies have performed: While fluid challenges are common, this specific approach using a mini-bolus in spontaneously breathing patients is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Patients with spontaneous breathing
* Patients in whom a fluid challenge is indicated because they present acute circulatory failure (which is defined as systolic blood pressure less than 90 mmHg or the need for vasopressors (norepinephrine more than 0.1 µg/kg/min) to maintain a systolic blood pressure more than 90 mmHg (14), and at least one sign of inadequate tissue perfusion:

  * urine output of below 0.5ml/kg per hour over 1 hour
  * tachycardia (heart rate of greater than 100 beats per minute)
  * mottled skin.
  * lactate \> 2 mmol/l

Exclusion Criteria:

* Cardiac arrest
* Acute respiratory distress syndrome
* Coma Glasgow Scale \< 14
* Age of less than 18 years
* Moribund patients
* Pregnant patients
* impossibility to perform passive leg raising (PLR) (trauma patients, lower extremity amputees, and prone patients)
* Patients with cardiac arrhythmias
* Patients with cardiogenic pulmonary oedema

Where this trial is running

Monastir and 1 other locations

• Emergency Departement — Monastir, Tunisia (Recruiting)
• Emergency department — Monastir, Tunisia (Recruiting)

Study contacts

• Principal investigator: Semir Nouira, Prof — University Hospital Fattouma Bourguiba Monastir , Emergency Department .
• Study coordinator: Semir Nouira, Prof

Conditions Fluid Therapy