Fluid ResponsivenessNCT04574011
Fluid Responsiveness in Spontaneously Ventilating Patient
A study testing Passive leg raising in people with Fluid Responsiveness, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find out if non-invasive dynamic parameters can predict fluid responsiveness in spontaneous breathing patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- Passive leg raising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2021to 21 Jul 2021
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- for patients undergoing surgery under actual spinal anesthesia whose estimated blood loss during surgery is moderate to high (e.g. total knee arthroplasty, total hip arthroplasty)
- Patients with a history of cerebrovascular disease
- Patients with a history of 1 or 2 vessel disease
- Left ventricle ejection fraction (LVEF) Patients with 30% or more and less than 55% of these patients
- Patients who need close hemodynamic monitoring during operation
- ASA (American Society of Anesthesiology) physical status classification system I, II, III
- no difficulty in passive leg raising maneuver
Who cannot join
- Patients unable to communicate
- Patients who cannot or have difficulty in PLR (passive leg raising) maneuver (patients who cause pain when performing PLR due to trauma of the lower extremities, patients with spine disease that causes pain during PLR, and patient applying splint due to a fracture of the lower extremity)
- Patients unable to attach the finger cuff of the ClearSight sytem to one of the fingers of both hands. (Patients applying a splint due to a fracture of both upper limbs, etc.)
- Patients unable to perform transthoracic ultrasound examination (multiple trauma patients with rib fracture, etc.)
- Patients having difficulty obtaining blood pressure waveforms through the ClearSight system due to poor peripheral vascular perfusion (uncontrolled diabetes patients, patients with peripheral vascular disease, etc.)
- Patients with arrhythmia with moderate or higher risk such as atrial fibrillation or atrial flutter
- Heart failure patients with less than 30% of the left ventricular ejection fraction(LVEF) on echocardiography or patients with moderate to severe left ventricular wall motor dysfunction, or patients with cardiovascular disease of 3 vessel disease
- Other patients who are not appropriate to participate in the study as judged by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongro-gu, 03080
Youngwon Kim, M.D, 82-2072-3283, youngwon.md@gmail.com
About this study
Official title: Prediction of Fluid Responsiveness With Non-invasive Dynamic Parameters in Spontaneous Breathing Patients
The purpose of this study is to find out if non-invasive dynamic parameters can predict fluid responsiveness in spontaneous breathing patients.
Read the detailed description
Knowing when to give fluids to the patient is very important in fluid therapy.It is appropriate to administer it to patients whose cardiac output will increase when the fluid is administered (a patient with fluid responsiveness). Appropriate fluid administration can hemodynamically stabilize the patient's condition and reduce unnecessary fluid administration, thereby reducing complications that occur when fluid is insufficient or excessive fluid is administered.
The most commonly used dynamic variables in clinical practice are pulse pressure variation (PPV), stroke volume variation (SVV), and systolic pressure variation that can be obtained by invasive arterial tube insertion. However, recently a non-invasive monitoring method is being used in more and more areas, and in many cases it is necessary to closely monitor the patient's hemodynamic status without mounting an arterial catheter. Therefore, if the variables measured by a non-invasive method can predict fluid responsiveness at a reliable level, it will be of great help in clinical practice.
According to previous studies, dynamic variables can relatively accurately predict fluid responsiveness only in patients undergoing mechanical ventilation. However, in actual clinic, it is necessary to evaluate fluid reactivity even in patients who are not under mechanical positive pressure ventilation. Accurate fluid treatment should be performed during or after surgery under spinal anesthesia in the recovery room. In addition, there are cases in which dynamic variables must be monitored non-invasively in spontaneous breathing patients who do not undergo mechanical ventilation even in intensive care units.
It is clinically meaningful to predict fluid responsiveness in spontaneous breathing patients using such a non-invasive method of monitoring. However, there is limited data on how to evaluate fluid responsiveness in these patient groups. Therefore, the purpose of this study is to evaluate whether fluid responsiveness can be predicted in spontaneous breathing patients using non-invasive dynamic variables.
- Conditions
- Fluid Responsiveness
- Being tested
- Passive leg raising
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg raisingDiagnostic test
Raise the patient's lower limb at a 45 degree angle while lying down
| Study group | Role | What they receive |
|---|---|---|
| Fluid challenge responder | Experimental | If the ratio of the stroke volume change after passive leg raising is the same or larger than 10%, the patient is assigned to RESPONDER group. Receives: Diagnostic Test: Passive leg raising |
| Fluid challenge non-responder | Experimental | If the ratio of the stroke volume change after passive leg raising is less than 10%, the patient is assigned to RESPONDER group. Receives: Diagnostic Test: Passive leg raising |
What is being measured
The primary outcome is the main question the study is designed to answer.
ClearSight PPV
Pulse pressure variation measured by ClearSight System arterial waveform
Measured: before induction, 20 minutes
Secondary outcomes (5)
ClearSight SVV
Stroke volume variation measured by ClearSight System
Measured: before induction, 20 minutes
normal ventilation △IVC (inferior vena cava) diameter
△IVC diameter variation on normal ventilation
Measured: before induction, 20 minutes
augmented ventilation △IVC (inferior vena cava) diameter
△IVC diameter variation on augmented ventilation
Measured: before induction, 20 minutes
normal ventilation △POP (pulse oximeter plethysmography)
△POP on normal ventilation
Measured: before induction, 20 minutes
augmented ventilation △POP (pulse oximeter plethysmography)
△POP on augmented ventilation
Measured: before induction, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start5 Mar 2021 (estimated)
- Primary completion11 Jun 2021 (estimated)
- Study completion21 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jintae Kim, M.D, Principal investigator, SNUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574011
- Sponsor's protocol ID
- H-2010-013-1161
- Status last verified
- Feb 2021
- First submitted
- 23 Sep 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cavallaro F, Sandroni C, Antonelli M. Functional hemodynamic monitoring and dynamic indices of fluid responsiveness. Minerva Anestesiol. 2008 Apr;74(4):123-35. Epub 2008 Jan 24.
PubMed 18212731Drvar Z, Pavlek M, Drvar V, Tomasevic B, Baronica R, Peric M. [Stroke volume and pulse pressure variation are good predictors of fluid responsiveness in sepsis patients]. Acta Med Croatica. 2013 Dec;67(5):407-14. Croatian.
PubMed 24979881Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.
PubMed 25230102Slagt C, Malagon I, Groeneveld AB. Systematic review of uncalibrated arterial pressure waveform analysis to determine cardiac output and stroke volume variation. Br J Anaesth. 2014 Apr;112(4):626-37. doi: 10.1093/bja/aet429. Epub 2014 Jan 14.
PubMed 24431387Vos JJ, Poterman M, Salm PP, Van Amsterdam K, Struys MM, Scheeren TW, Kalmar AF. Noninvasive pulse pressure variation and stroke volume variation to predict fluid responsiveness at multiple thresholds: a prospective observational study. Can J Anaesth. 2015 Nov;62(11):1153-60. doi: 10.1007/s12630-015-0464-2. Epub 2015 Sep 3.
PubMed 26335905Thiel SW, Kollef MH, Isakow W. Non-invasive stroke volume measurement and passive leg raising predict volume responsiveness in medical ICU patients: an observational cohort study. Crit Care. 2009;13(4):R111. doi: 10.1186/cc7955. Epub 2009 Jul 8.
PubMed 19586543Chaves RCF, Correa TD, Neto AS, Bravim BA, Cordioli RL, Moreira FT, Timenetsky KT, de Assuncao MSC. Assessment of fluid responsiveness in spontaneously breathing patients: a systematic review of literature. Ann Intensive Care. 2018 Feb 9;8(1):21. doi: 10.1186/s13613-018-0365-y.
PubMed 29427013
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness With Non-invasive Dynamic Parameters in Spontaneous Breathing Patients
- ClinicalTrials.gov ID
- NCT04574011
- Acronym / sponsor ID
- H-2010-013-1161
- Conditions
- Fluid Responsiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Mar 2021 (estimated)
- Primary completion
- 11 Jun 2021 (estimated)
- Study completion
- 21 Jul 2021 (estimated)
- First posted
- 5 Oct 2020 (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.
The purpose of this study is to find out if non-invasive dynamic parameters can predict fluid responsiveness in spontaneous breathing patients.
Detailed description
Knowing when to give fluids to the patient is very important in fluid therapy.It is appropriate to administer it to patients whose cardiac output will increase when the fluid is administered (a patient with fluid responsiveness). Appropriate fluid administration can hemodynamically stabilize the patient's condition and reduce unnecessary fluid administration, thereby reducing complications that occur when fluid is insufficient or excessive fluid is administered.
The most commonly used dynamic variables in clinical practice are pulse pressure variation (PPV), stroke volume variation (SVV), and systolic pressure variation that can be obtained by invasive arterial tube insertion. However, recently a non-invasive monitoring method is being used in more and more areas, and in many cases it is necessary to closely monitor the patient's hemodynamic status without mounting an arterial catheter. Therefore, if the variables measured by a non-invasive method can predict fluid responsiveness at a reliable level, it will be of great help in clinical practice.
According to previous studies, dynamic variables can relatively accurately predict fluid responsiveness only in patients undergoing mechanical ventilation. However, in actual clinic, it is necessary to evaluate fluid reactivity even in patients who are not under mechanical positive pressure ventilation. Accurate fluid treatment should be performed during or after surgery under spinal anesthesia in the recovery room. In addition, there are cases in which dynamic variables must be monitored non-invasively in spontaneous breathing patients who do not undergo mechanical ventilation even in intensive care units.
It is clinically meaningful to predict fluid responsiveness in spontaneous breathing patients using such a non-invasive method of monitoring. However, there is limited data on how to evaluate fluid responsiveness in these patient groups. Therefore, the purpose of this study is to evaluate whether fluid responsiveness can be predicted in spontaneous breathing patients using non-invasive dynamic variables.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid challenge responder | Experimental | Diagnostic Test: Passive leg raisingIf the ratio of the stroke volume change after passive leg raising is the same or larger than 10%, the patient is assigned to RESPONDER group. |
| Fluid challenge non-responder | Experimental | Diagnostic Test: Passive leg raisingIf the ratio of the stroke volume change after passive leg raising is less than 10%, the patient is assigned to RESPONDER group. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- for patients undergoing surgery under actual spinal anesthesia whose estimated blood loss during surgery is moderate to high (e.g. total knee arthroplasty, total hip arthroplasty)
- Patients with a history of cerebrovascular disease
- Patients with a history of 1 or 2 vessel disease
- Left ventricle ejection fraction (LVEF) Patients with 30% or more and less than 55% of these patients
- Patients who need close hemodynamic monitoring during operation
Key exclusion criteria (8 listed)
- Patients unable to communicate
- Patients who cannot or have difficulty in PLR (passive leg raising) maneuver (patients who cause pain when performing PLR due to trauma of the lower extremities, patients with spine disease that causes pain during PLR, and patient applying splint due to a fracture of the lower extremity)
- Patients unable to attach the finger cuff of the ClearSight sytem to one of the fingers of both hands. (Patients applying a splint due to a fracture of both upper limbs, etc.)
- Patients unable to perform transthoracic ultrasound examination (multiple trauma patients with rib fracture, etc.)
- Patients having difficulty obtaining blood pressure waveforms through the ClearSight system due to poor peripheral vascular perfusion (uncontrolled diabetes patients, patients with peripheral vascular disease, etc.)
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 raisingRaise the patient's lower limb at a 45 degree angle while lying down | Diagnostic test | Fluid challenge non-responder, Fluid challenge responder |
Primary outcome
ClearSight PPV
Time frame: before induction, 20 minutes
Pulse pressure variation measured by ClearSight System arterial waveform
5 secondary outcomes
ClearSight SVV
Time frame: before induction, 20 minutes
normal ventilation △IVC (inferior vena cava) diameter
Time frame: before induction, 20 minutes
augmented ventilation △IVC (inferior vena cava) diameter
Time frame: before induction, 20 minutes
normal ventilation △POP (pulse oximeter plethysmography)
Time frame: before induction, 20 minutes
augmented ventilation △POP (pulse oximeter plethysmography)
Time frame: before induction, 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 18212731Cavallaro F, Sandroni C, Antonelli M. Functional hemodynamic monitoring and dynamic indices of fluid responsiveness. Minerva Anestesiol. 2008 Apr;74(4):123-35. Epub 2008 Jan 24.
- Background: PubMed 24979881Drvar Z, Pavlek M, Drvar V, Tomasevic B, Baronica R, Peric M. [Stroke volume and pulse pressure variation are good predictors of fluid responsiveness in sepsis patients]. Acta Med Croatica. 2013 Dec;67(5):407-14. Croatian.
- Background: PubMed 25230102Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.
- Background: PubMed 24431387Slagt C, Malagon I, Groeneveld AB. Systematic review of uncalibrated arterial pressure waveform analysis to determine cardiac output and stroke volume variation. Br J Anaesth. 2014 Apr;112(4):626-37. doi: 10.1093/bja/aet429. Epub 2014 Jan 14.
- Background: PubMed 26335905Vos JJ, Poterman M, Salm PP, Van Amsterdam K, Struys MM, Scheeren TW, Kalmar AF. Noninvasive pulse pressure variation and stroke volume variation to predict fluid responsiveness at multiple thresholds: a prospective observational study. Can J Anaesth. 2015 Nov;62(11):1153-60. doi: 10.1007/s12630-015-0464-2. Epub 2015 Sep 3.
- Background: PubMed 19586543Thiel SW, Kollef MH, Isakow W. Non-invasive stroke volume measurement and passive leg raising predict volume responsiveness in medical ICU patients: an observational cohort study. Crit Care. 2009;13(4):R111. doi: 10.1186/cc7955. Epub 2009 Jul 8.
- Background: PubMed 29427013Chaves RCF, Correa TD, Neto AS, Bravim BA, Cordioli RL, Moreira FT, Timenetsky KT, de Assuncao MSC. Assessment of fluid responsiveness in spontaneously breathing patients: a systematic review of literature. Ann Intensive Care. 2018 Feb 9;8(1):21. doi: 10.1186/s13613-018-0365-y.
- Individual participant dataSharing planned: No
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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.
Jintae Kim, M.D principal investigator
SNUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive leg raising in people with Fluid Responsiveness, run by Seoul National University Hospital at 1 site in South Korea.
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 7 inclusion and 8 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 2 Mar 2021. 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 South Korea. 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 Youngwon Kim, M.D (82-2072-3283, youngwon.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ClearSight PPV (time frame: before induction, 20 minutes). 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 NCT04574011, which also lists 7 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 2 Mar 2021.