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Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department (MIBORED)

Primary Purpose

Fluid Therapy

Status
Recruiting
Phase
Early Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
Mini bolus 50
MINI bolus100
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluid Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency DepartementRecruiting
  • Emergency departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mini Bolus 50

Mini Bolus 100

Arm Description

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

receiving a "mini-bolus B":100 ml of crystalloid solution, regularly infused over 30 seconds

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2022
Last Updated
May 13, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05369559
Brief Title
Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
Acronym
MIBORED
Official Title
Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
August 22, 2023 (Anticipated)
Study Completion Date
May 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 or 100 ml, can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
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 benefit from an intravascular volume expansion, since they are in the horizontal portion of the Frank-Starling curve. Thus, an accurate assessment of fluid responsiveness prior to volume expansion is mandatory to avoid fluid overload, which has been associated with increased morbidity and mortality in critically ill patients. Fluid challenge, which consists of administering fluid to assess volume responsiveness, is widely performed. However, repeated fluid challenges, several times a day, can be harmful Indeed, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading can compromise micro-vascular perfusion and oxygen delivery or aggravate peripheral and pulmonary oedema. For many years, spontaneous breathing was considered a major limitation to assess fluid responsiveness in critically ill patients . Nevertheless, Guinot et al has shown that an increase in stroke volume of over 7% accurately predicted fluid responsiveness in spontaneously breathing patients under spinal anaesthesia, using a 100 ml fluid infusion. In this study, the investigator test the hypothesis that a mini-bolus fluid challenge, of either 50 ml or 100 ml, can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability. 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. Fluid challenge responsiveness: Fluid responsiveness is defined as an increase in the cardiac output measured using FloTrac-Vigileo monitor (∆CO-PLR > 10%) after the PLR, separating the studied population into responders and non-responders. Measurements: Patients characteristics, including age and sex, are recorded at admission. The aetiology of acute circulatory failure, the inotropic and/or vasopressor support (epinephrine, norepinephrine and dobutamine) and the APACHE II score are recorded. The following hemodynamic variables are recorded: heart rate (beats per minute), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and mean arterial blood pressure (mmHg). These variables are collected at baseline (T0), immediately before mini-bolus infusion (T50b, T50a, T100b and T100a), and immediately before the PLR manoeuvre (TPLRb and TPLRa). Cardiac output (CO) and stroke volume (SV) are measured using both an EsCCO monitor (COescco and SVescco) and a FloTrac transducer connected to a Vigileo monitor (COflotrac and SVflotrac). CO and SV are measured at baseline, before and after each mini-bolus infusion, and before and after passive leg raising. They are recorded at the moment when they plateau. The hemodynamic variables cited above are also recorded at that time. Changes -induced by the mini-boluses and by the PLR- in all parameters were measured; these were referred to as ∆[parameter]50 and ∆[parameter]100, and ∆[parameter]PLR. If patients were treated with norepinephrine, the dose remained unchanged from before volume expansion until all hemodynamic measurements were complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The fluid challenge is given intravenously via a specific venous line. Patients are assigned in a random chronological order to: receive a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds and receive a "mini-bolus B":100 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mini Bolus 50
Arm Type
Active Comparator
Arm Description
receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds
Arm Title
Mini Bolus 100
Arm Type
Active Comparator
Arm Description
receiving a "mini-bolus B":100 ml of crystalloid solution, regularly infused over 30 seconds
Intervention Type
Combination Product
Intervention Name(s)
Mini bolus 50
Intervention Description
receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds
Intervention Type
Combination Product
Intervention Name(s)
MINI bolus100
Intervention Description
receiving a "mini-bolus A":100 ml of crystalloid solution, regularly infused over 30 seconds
Primary Outcome Measure Information:
Title
Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .
Description
Predicting fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
Time Frame
at 3 minutes following fluid load in the day of admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semir Nouira, Prof
Phone
+21673106046
Email
semir.nouira.urg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Semir Nouira, Prof
Phone
+21673106000
Email
semir.nouira.urg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, Prof
Organizational Affiliation
University Hospital Fattouma Bourguiba Monastir , Emergency Department .
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Departement
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, professor
Phone
73 106 085
Ext
216
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name & Degree
kouraichi cyrine, MD
Phone
55598213
Ext
216
Email
cyrinekouraichi@hotmail.com
First Name & Middle Initial & Last Name & Degree
semir nouira, professor
Facility Name
Emergency department
City
Monastir
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, head chief
Phone
+21673106046
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name & Degree
Semir Nouira
Phone
+21673106000
Email
semir.nouira.urg@gmail.com

12. IPD Sharing Statement

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Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department

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