RecruitingEarly Phase 1NCT05369559

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

Sponsor

University of Monastir

Enrollment

1,000 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

Fluid Therapy

Summary

Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure.we test the hypothesis that a mini-bolus fluid challenge, of either 50 ml , can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria9

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

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Interventions

COMBINATION_PRODUCTMini bolus 50

receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds

DIAGNOSTIC_TESTpassive leg rising test

Passive leg raising technique: Initially, the patient is placed semi-recumbent with the head of the bed at 45°. After recording baseline measurement, the head of the bed is lowered and the legs are elevated to 45° for 2 minutes