Fluid ResponsivenessPHOENIXNCT06390423
Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness
An observational study of Fluid Responsiveness, run by CentraCare at 1 site in United States.
Trial summary
In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome)… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- Passive leg raise, SVI via bioreactance, Echo based VTI
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to Jun 2025
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Screening criteria: 1. New onset of hypotension: MAP < 65 mm HG for > 5 min 2. Escalation in Nor-epinephrine needs> 0.03 ug/kg/min 3. High MAP goal Low Urine output < 0.5ml/kg/hr for > 2 hours Elevated Lactate > 4 moles/L Decreased Lactate clearance (< 40%) 4. Bedside Echo Inc. VTI No obvious Hypovolemia No Low EF or No Pericardial effusion
Who may be able to join
- Age between 30 - 90 years
- Diagnosis of Vasodilatory Shock with no other obvious cause of hypotension
- Diagnosis of ARDS with PF ratio < 150 , PEEP > 8
- Patients who are under paralysis or deeply sedated, on a mechanical ventilator
Who cannot join
- Patients with arrhythmias including atrial fibrillation
- Patients with chest tube, intra-abdominal hypertension or with its risk factors
- Patients with structural heart disease including pulmonary hypertension (RVSP > 45) and heart failure
- Patients on extracorporeal support such as ECMO, CRRT or MCS.
- Patients with COPD with a premorbid FEV1 < 1.5 L
- Severe atherosclerotic vascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Cloud Hospital
Saint Cloud, Minnesota, 56303
Ramakanth Pata, MD FCCP, 320-240-2207, cookybrey1@gmail.com
About this study
Official title: Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates Such as Pulse Pressure Variation (PPV), End-tidal CO2 (Carbon Dioxide), Bioreactance (Stroke Volume Index -SVI) and Velocity Time Integral on Echocardiographic Exam for Fluid Responsiveness in Patients With Moderately Severe ARDS (Acute Respiratory Distress Syndrome)
In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome) can increase mortality. It has been estimated that only 50% of hemodynamically unstable critically ill patients are volume responsive, hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus.
Read the detailed description
Fluid responsiveness in patients with moderate to severe ARDS is crucial, as additional unnecessary fluid may be harmful. Various techniques of hemodynamic assessment exist, each with its own advantages and limitations. This study compares different techniques of preload responsiveness that include passive leg raise (PLR) and mini-fluid challenge induced changes in Pulse pressure variation (PPV), End tidal CO2, Bioreactance based Stroke volume index (SVI) and velocity time integral (VTI) on Echocardiogram.
Study protocol :
Baseline Echo with VTI will be obtained Bed side monitor will be set to display PPV and end tidal CO2 Baxter Starling system will be connected to the patient All baseline values will be recorded Tidal volume will be temporarily adjusted to 8 ml/kg , which will be reverted back to 6ml/kg after the measurements. This has proven to be a safe maneuver.
All the above hemodynamic assessments will be performed for eligible patients by measuring before and after PLR and repositioning to baseline. VTI will be estimated by bed side Echocardiogram. SVI will be estimated using the Starling system (Baxter). PPV and End tidal CO2 will be recorded from the bed side monitors.
Fluid responsiveness is presumed with a change in VTI of 10%. For these patients a mini-fluid challenge of 250 cc of crystalloids (NS, RL or Normosol) will be given over 10 min and PPV, VTI, End tidal CO2 and SVI will be recorded before and after fluid challenge. Patients with VTI change of < 10%, as non-responders, who will also be included in the analysis for assessment of reliability using the ROC curves. hemodynamic assessments and repeated fluid challenge will be considered as needed. Stability of vasopressor dose with maximum of 500 cc of crystalloid will be considered as positive fluid responder. This cohort of patients will be considered as gold standard for preload responsiveness and will be categorized based on a nominal scale. Patients who need higher vasopressor support despite 1L of crystalloid within 3 hours will be considered fluid non-responders.
Data collection:
De-identified data will be recorded. Age, BMI ( body mass index), Charleston co-morbidity index, baseline PPV, End-tidal CO2, SVI, VTI, post PLR, post fluid challenge, return to baseline, PF ratio, PEEP (positive end-expiratory pressure), SOFA (sequential organ function assessment) Score on the day of the test will be recorded.
Statistical Analysis:
Microsoft Excel will be used to record data on an institutional computer. Once the data is collected, it will be exported for statistical analysis. Jamovi will be utilized for statistical analysis. Baseline characteristics will be compared using a T-test if normative distribution or non-parametric test such as Mann Whitney U test. Reliability and accuracy will be detected using ROC curve assessment. In addition, the Youden index approach will be utilized to identify cut-offs of each of the variables and their change. (PPV, SVI,VTI and End tidal CO2). All the delta values will be compared with pearson correlation with a scatter plot and line of identity. Agreement between variables will be done using Bland-Altman analysis. If necessary, values will be transformed into Z scores. For all comparisons, a p-value of <0.05 was considered significant.
- Conditions
- Fluid Responsiveness
- Being tested
- Passive leg raise, SVI via bioreactance, Echo based VTI
- Keywords
- Pre-load responsiveness, Passive leg raise, Mini-fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg raise, SVI via bioreactance, Echo based VTIDiagnostic test
No interventions other than fluid challenge
| Study group | Role | What they receive |
|---|---|---|
| Fluid responder | Stability of vasopressor dose with maximum of 500 cc of crystalloids Receives: Diagnostic Test: Passive leg raise, SVI via bioreactance, Echo based VTI | |
| Fluid non responder | Escalating dose of vasopressors despite 1 L of crystalloid fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min
We shall assess the need for vasopressor dose e.g nor-epinephrine dose. If the dose remains constant after fluid bolus until 3 hours, we shall consider them fluid resposive. If the dose requirement goes up despite fluid bolus, we shall label them fluid un-responsive
Measured: 3 hours after the initial passive leg raise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jul 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluid ResponsivenessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CentraCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramakanth Pata, CentraCare
- Investigators
- Ramakanth Pata, MD FCCP, Principal investigator, Centracare health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390423
- Sponsor's protocol ID
- RAMPHOENIX
- Acronym
- PHOENIX
- Status last verified
- Aug 2024
- First submitted
- 25 Apr 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monnet X, Teboul JL. Passive leg raising: five rules, not a drop of fluid! Crit Care. 2015 Jan 14;19(1):18. doi: 10.1186/s13054-014-0708-5. No abstract available.
PubMed 25658678Monnet X, Bataille A, Magalhaes E, Barrois J, Le Corre M, Gosset C, Guerin L, Richard C, Teboul JL. End-tidal carbon dioxide is better than arterial pressure for predicting volume responsiveness by the passive leg raising test. Intensive Care Med. 2013 Jan;39(1):93-100. doi: 10.1007/s00134-012-2693-y. Epub 2012 Sep 19.
PubMed 22990869
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates Such as Pulse Pressure Variation (PPV), End-tidal CO2 (Carbon Dioxide), Bioreactance (Stroke Volume Index -SVI) and Velocity Time Integral on Echocardiographic Exam for Fluid Responsiveness in Patients With Moderately Severe ARDS (Acute Respiratory Distress Syndrome)
- ClinicalTrials.gov ID
- NCT06390423
- Acronym / sponsor ID
- PHOENIX / RAMPHOENIX
- Conditions
- Fluid Responsiveness
- Keywords
- Pre-load responsiveness, Passive leg raise, Mini-fluid challenge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- CentraCareUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome) can increase mortality. It has been estimated that only 50% of hemodynamically unstable critically ill patients are volume responsive, hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus.
Detailed description
Fluid responsiveness in patients with moderate to severe ARDS is crucial, as additional unnecessary fluid may be harmful. Various techniques of hemodynamic assessment exist, each with its own advantages and limitations. This study compares different techniques of preload responsiveness that include passive leg raise (PLR) and mini-fluid challenge induced changes in Pulse pressure variation (PPV), End tidal CO2, Bioreactance based Stroke volume index (SVI) and velocity time integral (VTI) on Echocardiogram.
Study protocol :
Baseline Echo with VTI will be obtained Bed side monitor will be set to display PPV and end tidal CO2 Baxter Starling system will be connected to the patient All baseline values will be recorded Tidal volume will be temporarily adjusted to 8 ml/kg , which will be reverted back to 6ml/kg after the measurements. This has proven to be a safe maneuver.
All the above hemodynamic assessments will be performed for eligible patients by measuring before and after PLR and repositioning to baseline. VTI will be estimated by bed side Echocardiogram. SVI will be estimated using the Starling system (Baxter). PPV and End tidal CO2 will be recorded from the bed side monitors.
Fluid responsiveness is presumed with a change in VTI of 10%. For these patients a mini-fluid challenge of 250 cc of crystalloids (NS, RL or Normosol) will be given over 10 min and PPV, VTI, End tidal CO2 and SVI will be recorded before and after fluid challenge. Patients with VTI change of < 10%, as non-responders, who will also be included in the analysis for assessment of reliability using the ROC curves. hemodynamic assessments and repeated fluid challenge will be considered as needed. Stability of vasopressor dose with maximum of 500 cc of crystalloid will be considered as positive fluid responder. This cohort of patients will be considered as gold standard for preload responsiveness and will be categorized based on a nominal scale. Patients who need higher vasopressor support despite 1L of crystalloid within 3 hours will be considered fluid non-responders.
Data collection:
De-identified data will be recorded. Age, BMI ( body mass index), Charleston co-morbidity index, baseline PPV, End-tidal CO2, SVI, VTI, post PLR, post fluid challenge, return to baseline, PF ratio, PEEP (positive end-expiratory pressure), SOFA (sequential organ function assessment) Score on the day of the test will be recorded.
Statistical Analysis:
Microsoft Excel will be used to record data on an institutional computer. Once the data is collected, it will be exported for statistical analysis. Jamovi will be utilized for statistical analysis. Baseline characteristics will be compared using a T-test if normative distribution or non-parametric test such as Mann Whitney U test. Reliability and accuracy will be detected using ROC curve assessment. In addition, the Youden index approach will be utilized to identify cut-offs of each of the variables and their change. (PPV, SVI,VTI and End tidal CO2). All the delta values will be compared with pearson correlation with a scatter plot and line of identity. Agreement between variables will be done using Bland-Altman analysis. If necessary, values will be transformed into Z scores. For all comparisons, a p-value of <0.05 was considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid responder | – | Diagnostic Test: Passive leg raise, SVI via bioreactance, Echo based VTIStability of vasopressor dose with maximum of 500 cc of crystalloids |
| Fluid non responder | – | –Escalating dose of vasopressors despite 1 L of crystalloid fluid challenge |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Screening criteria: 1. New onset of hypotension: MAP < 65 mm HG for > 5 min 2. Escalation in Nor-epinephrine needs> 0.03 ug/kg/min 3. High MAP goal Low Urine output < 0.5ml/kg/hr for > 2 hours Elevated Lactate > 4 moles/L Decreased Lactate clearance (< 40%) 4. Bedside Echo Inc. VTI No obvious Hypovolemia No Low EF or No Pericardial effusion
Key inclusion criteria (4 listed)
- Age between 30 - 90 years
- Diagnosis of Vasodilatory Shock with no other obvious cause of hypotension
- Diagnosis of ARDS with PF ratio < 150 , PEEP > 8
- Patients who are under paralysis or deeply sedated, on a mechanical ventilator
Key exclusion criteria (6 listed)
- Patients with arrhythmias including atrial fibrillation
- Patients with chest tube, intra-abdominal hypertension or with its risk factors
- Patients with structural heart disease including pulmonary hypertension (RVSP > 45) and heart failure
- Patients on extracorporeal support such as ECMO, CRRT or MCS.
- Patients with COPD with a premorbid FEV1 < 1.5 L
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 |
|---|---|---|
| Passive leg raise, SVI via bioreactance, Echo based VTINo interventions other than fluid challenge | Diagnostic test | Fluid responder |
Primary outcome
Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min
Time frame: 3 hours after the initial passive leg raise
We shall assess the need for vasopressor dose e.g nor-epinephrine dose. If the dose remains constant after fluid bolus until 3 hours, we shall consider them fluid resposive. If the dose requirement goes up despite fluid bolus, we shall label them fluid un-responsive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 25658678Monnet X, Teboul JL. Passive leg raising: five rules, not a drop of fluid! Crit Care. 2015 Jan 14;19(1):18. doi: 10.1186/s13054-014-0708-5. No abstract available.
- Background: PubMed 22990869Monnet X, Bataille A, Magalhaes E, Barrois J, Le Corre M, Gosset C, Guerin L, Richard C, Teboul JL. End-tidal carbon dioxide is better than arterial pressure for predicting volume responsiveness by the passive leg raising test. Intensive Care Med. 2013 Jan;39(1):93-100. doi: 10.1007/s00134-012-2693-y. Epub 2012 Sep 19.
- Individual participant dataSharing planned: No
Related trials for Fluid Responsiveness
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
RecruitingObservational study
Dynamic SvO2 in Predicting Fluid Responsiveness in Septic Shock
Sepsis and Septic Shock
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Not yet recruitingObservational study
This Study Compares Two Noninvasive Dynamic Tools: Lung Ultrasound and Transthoracic Echocardiography Using LVOT VTI. It Aims to Measure the Sensitivity and Specificity of LUS in Guiding Fluid Resuscitation and Early Detection of Fluid Responsiveness and to Prevent Volume Overload
Septic Shock, Fluid Reponsiveness
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.
Ramakanth Pata, MD FCCP principal investigator
Centracare health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Responsiveness, run by CentraCare at 1 site in United States.
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 4 inclusion and 6 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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 Ramakanth Pata (320-240-2207, cookybrey1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min (time frame: 3 hours after the initial passive leg raise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390423, which also lists 2 linked publications.
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 22 Aug 2024.