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Search / Trial NCT05369559

Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

Launched by UNIVERSITY OF MONASTIR · May 5, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients who are critically ill and experiencing low blood pressure, known as acute circulatory failure. Researchers want to find out if giving a small amount of fluid, called a mini-bolus (just 50 ml), can help predict how well a patient will respond to further fluid treatment. The goal is to improve care for those who are struggling to maintain stable blood pressure and proper blood flow.

To participate in this trial, patients need to be between the ages of 18 and 100, be breathing on their own, and have signs of acute circulatory failure, such as very low blood pressure or a high heart rate. However, individuals who are in very critical condition, have certain serious medical issues, or are pregnant cannot take part. If eligible, participants will receive the mini-bolus fluid challenge and be monitored to see how their body responds. This research could lead to better treatment strategies for patients in the emergency department.

Gender

ALL

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

About University Of Monastir

The University of Monastir, a prominent educational and research institution in Tunisia, is dedicated to advancing medical and clinical research through its innovative programs and collaborations. With a strong emphasis on improving healthcare outcomes, the university actively sponsors clinical trials that explore new therapeutic approaches and enhance patient care. Leveraging its state-of-the-art facilities and a diverse team of experienced researchers and clinicians, the University of Monastir aims to contribute significantly to the global body of medical knowledge while fostering a culture of scientific inquiry and excellence.

Locations

Monastir, , Tunisia

Monastir, , Tunisia

Patients applied

0 patients applied

Trial Officials

Semir Nouira, Prof

Principal Investigator

University Hospital Fattouma Bourguiba Monastir , Emergency Department .

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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