Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

NCT05369559 | Recruiting Early Phase 1

• 1 other identifier: TN2020-NA T -INS-399
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .

  Predicting fluid responsiveness in spontaneously breathing patients with hemodynamic instability.

  at 3 minutes following fluid load in the day of admission

Study Arms (2)

Mini Bolus 50

ACTIVE COMPARATOR

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

Diagnostic Test: passive leg rising test

PLR

OTHER

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

Combination Product: Mini bolus 50

Interventions

Mini bolus 50 COMBINATION_PRODUCT

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

PLR

passive leg rising test DIAGNOSTIC_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

Mini Bolus 50

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (2)

Emergency Departement

Monastir, 5000, Tunisia

RECRUITING

Emergency department

Monastir, Tunisia

RECRUITING

Study Officials

• Semir Nouira, Prof

  University Hospital Fattouma Bourguiba Monastir , Emergency Department .

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Semir Nouira, Prof

CONTACT

+21673106046; semir.nouira.urg@gmail.com

Khaoula Bel Haj Ali, MD

CONTACT

99792724; belhajalikhaoula@yahoo.fr

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head chief, Emmergency Department ,University Hospital of Monastir

Model Details: The fluid challenge is given intravenously via a specific venous line. Patients are assigned in a random chronological order to: * receive a "mini-bolus ":50 ml of crystalloid solution, regularly infused over 30 seconds * and passive leg raising. 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: May 11, 2022
• Study Start: March 3, 2022
• Primary Completion: August 22, 2024
• Study Completion: May 22, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

TU (2)