NCT05369559 Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
| NCT ID | NCT05369559 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Monastir |
| Condition | Fluid Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2024-08-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 1,000 participants in total. It began in 2022-03-03 with a primary completion date of 2024-08-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
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
Contact & Investigator
Semir Nouira, Prof
PRINCIPAL INVESTIGATOR
University Hospital Fattouma Bourguiba Monastir , Emergency Department .
Frequently Asked Questions
Who can join the NCT05369559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fluid Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05369559 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05369559 currently recruiting?
Yes, NCT05369559 is actively recruiting participants. Contact the research team at semir.nouira.urg@gmail.com for enrollment information.
Where is the NCT05369559 trial being conducted?
This trial is being conducted at Monastir, Tunisia, Monastir, Tunisia.
Who is sponsoring the NCT05369559 clinical trial?
NCT05369559 is sponsored by University of Monastir. The principal investigator is Semir Nouira, Prof at University Hospital Fattouma Bourguiba Monastir , Emergency Department .. The trial plans to enroll 1,000 participants.