Fluid TherapyEarly Phase 1MIBOREDNCT05369559
Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
A Early Phase 1 study testing Mini bolus 50 and passive leg rising test in people with Fluid Therapy, run by University of Monastir at 2 sites in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Therapy
- What is being tested?
- Mini bolus 50 and passive leg rising test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesTunisia
- Study dates
- 3 Mar 2022to 22 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiac arrest
- Acute respiratory distress syndrome
- Coma Glasgow Scale < 14
- Age of less than 18 years
- Moribund patients
- Pregnant patients
Show all 9Show fewer
- impossibility to perform passive leg raising (PLR) (trauma patients, lower extremity amputees, and prone patients)
- Patients with cardiac arrhythmias
- Patients with cardiogenic pulmonary oedema
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites, 2 recruiting
- Recruiting
Emergency Departement
Monastir, 5000
Semir Nouira, professor, 73 106 085 ext. 216, semir.nouira@rns.tn
kouraichi cyrine, MD, 55598213 ext. 216, cyrinekouraichi@hotmail.com
- Recruiting
Emergency department
Monastir
Semir Nouira, head chief, +21673106046, semir.nouira@rns.tn
Semir Nouira, +21673106000, semir.nouira.urg@gmail.com
About this study
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.
Read the 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 .
In this study, the investigator test the hypothesis that a mini-bolus fluid challenge of 50 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), 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]PLR.
If patients were treated with norepinephrine, the dose remained unchanged from before volume expansion until all hemodynamic measurements were complete.
- Conditions
- Fluid Therapy
- Being tested
- Mini bolus 50, passive leg rising test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini bolus 50Combination product
receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds
passive leg rising testDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Mini Bolus 50 | Active comparator | receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds Receives: 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 Receives: Combination Product: Mini bolus 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 minutes following fluid load in the day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start3 Mar 2022
- Primary completion22 Aug 2024 (estimated)
- Study completion22 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 ":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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Prof, Principal investigator, University Hospital Fattouma Bourguiba Monastir , Emergency Department .
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369559
- Sponsor's protocol ID
- TN2020-NA T -INS-399
- Acronym
- MIBORED
- Status last verified
- Jul 2024
- First submitted
- 14 Mar 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
- ClinicalTrials.gov ID
- NCT05369559
- Acronym / sponsor ID
- MIBORED / TN2020-NA T -INS-399
- Conditions
- Fluid Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 22 Aug 2024 (estimated)
- Study completion
- 22 May 2025 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 .
In this study, the investigator test the hypothesis that a mini-bolus fluid challenge of 50 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), 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]PLR.
If patients were treated with norepinephrine, the dose remained unchanged from before volume expansion until all hemodynamic measurements were complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 ":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.
| Arm | Type | Receives |
|---|---|---|
| Mini Bolus 50 | Active comparator | Diagnostic Test: passive leg rising testreceiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds |
| PLR | Other | Combination Product: Mini bolus 50Passive 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- Cardiac arrest
- Acute respiratory distress syndrome
- Coma Glasgow Scale < 14
- Age of less than 18 years
- Moribund patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini bolus 50receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds | Combination product | PLR |
| passive leg rising testPassive 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 | Diagnostic test | Mini Bolus 50 |
Primary outcome
Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .
Time frame: at 3 minutes following fluid load in the day of admission
Predicting fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, Prof principal investigator
University Hospital Fattouma Bourguiba Monastir , Emergency Department .
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mini bolus 50 and passive leg rising test in people with Fluid Therapy, run by University of Monastir at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semir Nouira, Prof (+21673106046, semir.nouira.urg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness . (time frame: at 3 minutes following fluid load in the day of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.