Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
ID05369559

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

Led by University of Monastir · Updated on 2024-07-09

1000

Participants Needed

2

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how a small fluid test, called a mini-bolus fluid challenge, can predict whether critically ill patients who are breathing on their own and experiencing unstable blood flow will benefit from receiving more fluids. This is important because giving fluids to patients who do not need them can cause harm, such as swelling or poor oxygen delivery. The study focuses on patients with acute circulatory failure, which means their blood pressure is low or they need medications to support their heart function, and signs of poor tissue blood flow. The study compares two methods to assess fluid responsiveness: giving a 50 ml mini-bolus of crystalloid fluid over 30 seconds and performing a passive leg raising (PLR) test, where the patient's legs are lifted while lying down to see if their heart output improves. Researchers measure heart function using special monitors that track cardiac output and stroke volume before and after these tests. The mini-bolus and PLR are done during the emergency care period to see which predicts fluid responsiveness better. Participants will have their heart rate, blood pressure, and cardiac output monitored at different times: before and after the mini-bolus, and before and after the PLR test. Patient details like age, sex, cause of circulatory failure, medications, and severity scores are also recorded. The main outcome is how well the continuous cardiac output monitor predicts fluid responsiveness three minutes after the fluid test. Researchers keep medication doses stable during measurements and watch for any changes in heart performance. The study occurs during acute care, with close monitoring to assess treatment response and safety.

CONDITIONS

Brief Title

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are breathing spontaneously without mechanical ventilation
  • Patients with acute circulatory failure needing fluid challenge, defined as systolic blood pressure less than 90 mmHg or requiring vasopressors (norepinephrine > 0.1 µg/kg/min) to maintain blood pressure
  • Presence of at least one sign of poor tissue blood flow such as low urine output, fast heart rate over 100 beats per minute, mottled skin, or lactate level above 2 mmol/L
  • Age between 18 and 80 years
Not Eligible

You will not qualify if you...

  • History of cardiac arrest
  • Acute respiratory distress syndrome
  • Coma with Glasgow Scale less than 14
  • Age under 18 years
  • Patients near death (moribund)
  • Pregnant patients
  • Inability to perform passive leg raising (due to trauma, leg amputation, or prone position)
  • Patients with irregular heart rhythms (cardiac arrhythmias)
  • Patients with cardiogenic pulmonary edema

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of admission, assessments occur within minutes

Participants receive a mini-bolus fluid challenge of 50 ml crystalloid solution infused over 30 seconds and undergo passive leg raising to assess fluid responsiveness.

1 baseline visit with measurements before and after mini-bolus infusion and passive leg raising

Trial Site Locations

Total: 2 locations

1

Emergency Departement

Monastir, Tunisia, 5000

Actively Recruiting

2

Emergency department

Monastir, Tunisia

Actively Recruiting

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Research Team

S

Semir Nouira, Prof

K

Khaoula Bel Haj Ali, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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