Status:

RECRUITING

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

Lead Sponsor:

University of Monastir

Conditions:

Fluid Therapy

Eligibility:

All Genders

18-80 years

Phase:

EARLY_PHASE1

Brief 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 predic...

Detailed Description

Background: Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure. Nevertheless, approximately 50% of critically ill patients will not bene...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 3 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 22 2025

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT05369559

Start Date

March 3 2022

End Date

May 22 2025

Last Update

July 9 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Emergency Departement

Monastir, Tunisia, 5000

2

Emergency department

Monastir, Tunisia

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department | DecenTrialz