ShockNCT05211765
Respiratory Variation of Superior Vena Cava in Transthoracic View as a Fluid Responsiveness Predictor
An observational study of Shock, run by University of Chile at 1 site in Chile.
Trial summary
Fluid evaluation is relevant in critical care. Cardiac ultrasound is the first line of evaluation in hemodynamic characterization of patients in shock, to tailor therapy. Fluid responsiveness predictors allow to better decide when to administer fluids, and transesophagic view of superior vena cava is an effective one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Superior vena cava transthoracic evaluation
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 7 Mar 2021to Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ventilated critically ill patients with hemodynamic instability hospitalized in the intensive care unit.
Who may be able to join
- Patients >18 years,
- Hospitalized in the Intensive Care Unit (ICU) with length of stay under 7 days
- Under positive pressure ventilation with no inspiratory effort,
- With hemodynamic instability (defined as abnormal peripheral perfusion or increased blood lactic or vasopressor infusion of norepinephrine >0.1 ug/kg/min to achieve adequate mean arterial pressure)
Who cannot join
- Spontaneous ventilatory effort
- Lack of venous access
- Carrier of carbapenemase or clostridium difficile
- Lack of adequate superior vena cava (SVC) window (not allowing M-mode during both respiratory phases)
- Severe aortic regurgitation
- Impossibility to measure LVOT-VTI
- Extracorporeal membrane oxygenation.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 8380420
Diego Ugalde, md, +56974197896, diegougaldecastillo@gmail.com
About this study
Official title: Association of Respiratory Variation of Superior Vena Cava in Transthoracic View and Fluid Responsiveness in Critically Ill Patients
Fluid evaluation is relevant in critical care. Cardiac ultrasound is the first line of evaluation in hemodynamic characterization of patients in shock, to tailor therapy.
Fluid responsiveness predictors allow to better decide when to administer fluids, and transesophagic view of superior vena cava is an effective one. Recently a transthoracic view of the superior vena cava has been described.
The investigators aim to evaluate if the variations of superior vena cava can predict fluid responsiveness in critically il, ventilated patients.
Hypothesis: Respiratory variations of superior vena cava diameter, evaluated with transthoracic ultrasound, can predict fluid responsiveness
Read the detailed description
Prospective evaluation of diameter variability of the superior vena cava by transthoracic echocardiography as fluid responsiveness predictor in critically ill patients:
Background Fluid administration is frequent in critically ill patients, particularly during reanimation and its empirical use is recommended as an initial step during this phase.
However, even though excess fluid administration is associated to negative outcomes fluid use is still being empirical and with scarce application of responsiveness predictors before its indication.
Different measurements or maneuvers exist, that allow clinicians to predict if a patient would present a positive fluid response, usually defined as cardiac output increasing 15% when infusing 500ml of crystalloids, and application of these predictive parameters could have clinical benefits on outcomes by avoiding inappropriate fluid administration.
As for the variables used, different types stand out. In general, flow or pressure variations originated in cardiothoracic interaction, auto-infusion and reduced fluid test evaluations such as the "mini" o "micro" fluid tests, in addition venous diameter variations in ultrasound evaluation with variable accuracy depending on the context. However, cardiothoracic interaction variables might have false positive results when right ventricular failure is present, given the cyclic increment on its afterload induced by positive pressure ventilation, reducing right ventricle stroke volume limiting its application in established or unknown and probable right heart failure if and advanced hemodynamic monitoring has not been performed to rule it out.
In this context, venous evaluations and reduced volume fluid test have advantages, and particularly in patients in shock under positive pressure ventilation, superior vena cava variation, being a better predictor than inferior vena cava. However, traditionally, superior vena cava can only be observed with transesophageal echocardiography and that can be a limitation in resource limited settings. Recently a new transthoracic acoustic window has been described, using a vertical left parasternal approach that allows evaluation of the superior vena cave, and initially, this approach shows a good correlation with the transesophageal measurement, and acceptable feasibility in the pilot study patients.
In this way, it can be postulated as possible, to evaluate if the variability of superior vena cava diameter on a transthoracic approach can be used as a fluid responsiveness predictor in critically ill patients on positive pressure ventilation.
Hypothesis Superior vena cava diameter respiratory variation evaluated with transthoracic ultrasound can predict fluid responsiveness in critically ill patients in positive pressure ventilation.
Objective To evaluate if superior vena cava respiratory diameter variation is associated with fluid responsiveness, when compared with the mini fluid infusion of 100ml evaluated with expiratory left ventricle outflow tract velocity time integral (LVOT-VTI) before and after fluid administration.
Methods
After evaluation, inclusion and exclusion criteria checking:
A basal echocardiography is performed, main pattern and clinical data are recorded (age, sex, weight, height, main diagnosis, secondary diagnosis, length of stay, surgical procedures, sequential organ failure assesment (SOFA) score, renal replacement therapy), respiratory (ventilator mode, tidal volume, respiratory rate, positive end expiratory pressure (PEEP), plateau pressure, peak inspiratory pressure, autoPEEP, fraction of inspired oxygen (FiO2), I:E relation, total inspiratory time), hemodynamic data from unit monitors. (cardiac rate, systolic pressure, diastolic pressure, mean pressure, central venous pressure) and closest laboratory to evaluation (lactate, venous oxygen saturation (ScVO2), arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCO2), pH, base excess (BE), bicarbonate (HCO3), carbon dioxide (CO2) arterio-venous difference, )
- Superior vena cava evaluation, Respiratory variation observed in M mode and measured. Registry of expiratory and inspiratory diameter (evaluated in the same cardiac cycle phase)
- Using Apical 5 chamber view, basal LVOT-VTI would be obtained, 3 measurements in regular rhythms and 5 measurements in irregular rhythms such as atrial fibrillation. 100 ml will be infused without changing the view and end-expiratory LVOT-VTI would be obtained a minute after infusion in the same fashion as before.
- Considering ultrasound evaluation is part of standard patient care, informed consent was waived by the ethical board.
- For analysis, the proportion of variation in superior vena cava (SVC) and VTI variation would be calculated as percentage.
- All values will be registered in a google drive table and then included in microsoft excel for coding and analyzed with Stata 12.
- Fluid responsiveness will be defined as 10% increase in VTI with the "mini bolus" fluid test, considering the minimal detectable change.
- For analysis, receiver operator curve (ROC) statistic will be done in Stata 12.
- Summary variables of the population will be presented.
- For diagnostic evaluation, the tool "roctab" for receiver operating characteristic curve will be used, obtaining cut off values, sensitivity, specificity and gray area in addition to traditional area under curve (AUC). A dichotomic value for simple orientation will be selected with an ideally balanced sensitivity and specificity for general use. Linear correlation will be explored to detect a continuous relation between SVC variation and VTI increase.
- Window success will be recorded and proportion will be analysed during the months of the study to check for performance improvements that might be expected as a learning curve effect.
- Additional data might allow post hoc analysis including window feasibility in association with clinical variables and
- After the ultrasound evaluation, the result of the 100ml test will be informed to the treating physician.
- Sample size:
Considering a possible 50% loss with inadequate acoustic window, 100 evaluated patients would achieve at least 48 included to obtain AUC 0.7. (estimating 24 to be responders and 24 not responders)
- Conditions
- Shock
- Being tested
- Superior vena cava transthoracic evaluation
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior vena cava transthoracic evaluationDiagnostic test
The superior vena cava will be observed with a cardiac ultrasound machine, its diameter in different respiratory phases evaluated and compared with fluid response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
An increase of 10% or more in the left ventricle velocity time integral value (average of 3 in regular rhythms or 5 in irregular rhythms) measured with cardiac ultrasound in 5 chambers apical view after the infusion of 100ml bolus of intravenous crystalloid solution.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start7 Mar 2021
- Primary completionNov 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ShockStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Ugalde Castillo, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211765
- Sponsor's protocol ID
- 78/20
- Status last verified
- Nov 2023
- First submitted
- 28 Dec 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Probably database will be available if asked once completed.
Publications
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
PubMed 28101605Reuter DA, Chappell D, Perel A. The dark sides of fluid administration in the critically ill patient. Intensive Care Med. 2018 Jul;44(7):1138-1140. doi: 10.1007/s00134-017-4989-4. Epub 2017 Nov 11. No abstract available.
PubMed 29128963Malbrain MLNG, Van Regenmortel N, Saugel B, De Tavernier B, Van Gaal PJ, Joannes-Boyau O, Teboul JL, Rice TW, Mythen M, Monnet X. Principles of fluid management and stewardship in septic shock: it is time to consider the four D's and the four phases of fluid therapy. Ann Intensive Care. 2018 May 22;8(1):66. doi: 10.1186/s13613-018-0402-x.
PubMed 29789983Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care. 2015 Jun 15;19(1):251. doi: 10.1186/s13054-015-0970-1.
PubMed 26073560Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
PubMed 26162676Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.
PubMed 28817481Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.
PubMed 27858374Vistisen ST, Juhl-Olsen P. Where are we heading with fluid responsiveness research? Curr Opin Crit Care. 2017 Aug;23(4):318-325. doi: 10.1097/MCC.0000000000000421.
PubMed 28537997Michard F. Toward Precision Hemodynamic Management. Crit Care Med. 2017 Aug;45(8):1421-1423. doi: 10.1097/CCM.0000000000002458. No abstract available.
PubMed 28708687Vignon P, Repesse X, Begot E, Leger J, Jacob C, Bouferrache K, Slama M, Prat G, Vieillard-Baron A. Comparison of Echocardiographic Indices Used to Predict Fluid Responsiveness in Ventilated Patients. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1022-1032. doi: 10.1164/rccm.201604-0844OC.
PubMed 27653798Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.
PubMed 19237902Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.
PubMed 26825952Biais M, Ehrmann S, Mari A, Conte B, Mahjoub Y, Desebbe O, Pottecher J, Lakhal K, Benzekri-Lefevre D, Molinari N, Boulain T, Lefrant JY, Muller L; AzuRea Group. Clinical relevance of pulse pressure variations for predicting fluid responsiveness in mechanically ventilated intensive care unit patients: the grey zone approach. Crit Care. 2014 Nov 4;18(6):587. doi: 10.1186/s13054-014-0587-9.
PubMed 25658489Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.
PubMed 21792056Wu Y, Zhou S, Zhou Z, Liu B. A 10-second fluid challenge guided by transthoracic echocardiography can predict fluid responsiveness. Crit Care. 2014 May 27;18(3):R108. doi: 10.1186/cc13891.
PubMed 24886990
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Respiratory Variation of Superior Vena Cava in Transthoracic View and Fluid Responsiveness in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05211765
- Acronym / sponsor ID
- 78/20
- Conditions
- Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 27 Jan 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.
Fluid evaluation is relevant in critical care. Cardiac ultrasound is the first line of evaluation in hemodynamic characterization of patients in shock, to tailor therapy.
Fluid responsiveness predictors allow to better decide when to administer fluids, and transesophagic view of superior vena cava is an effective one. Recently a transthoracic view of the superior vena cava has been described.
The investigators aim to evaluate if the variations of superior vena cava can predict fluid responsiveness in critically il, ventilated patients.
Hypothesis: Respiratory variations of superior vena cava diameter, evaluated with transthoracic ultrasound, can predict fluid responsiveness
Detailed description
Prospective evaluation of diameter variability of the superior vena cava by transthoracic echocardiography as fluid responsiveness predictor in critically ill patients:
Background Fluid administration is frequent in critically ill patients, particularly during reanimation and its empirical use is recommended as an initial step during this phase.
However, even though excess fluid administration is associated to negative outcomes fluid use is still being empirical and with scarce application of responsiveness predictors before its indication.
Different measurements or maneuvers exist, that allow clinicians to predict if a patient would present a positive fluid response, usually defined as cardiac output increasing 15% when infusing 500ml of crystalloids, and application of these predictive parameters could have clinical benefits on outcomes by avoiding inappropriate fluid administration.
As for the variables used, different types stand out. In general, flow or pressure variations originated in cardiothoracic interaction, auto-infusion and reduced fluid test evaluations such as the "mini" o "micro" fluid tests, in addition venous diameter variations in ultrasound evaluation with variable accuracy depending on the context. However, cardiothoracic interaction variables might have false positive results when right ventricular failure is present, given the cyclic increment on its afterload induced by positive pressure ventilation, reducing right ventricle stroke volume limiting its application in established or unknown and probable right heart failure if and advanced hemodynamic monitoring has not been performed to rule it out.
In this context, venous evaluations and reduced volume fluid test have advantages, and particularly in patients in shock under positive pressure ventilation, superior vena cava variation, being a better predictor than inferior vena cava. However, traditionally, superior vena cava can only be observed with transesophageal echocardiography and that can be a limitation in resource limited settings. Recently a new transthoracic acoustic window has been described, using a vertical left parasternal approach that allows evaluation of the superior vena cave, and initially, this approach shows a good correlation with the transesophageal measurement, and acceptable feasibility in the pilot study patients.
In this way, it can be postulated as possible, to evaluate if the variability of superior vena cava diameter on a transthoracic approach can be used as a fluid responsiveness predictor in critically ill patients on positive pressure ventilation.
Hypothesis Superior vena cava diameter respiratory variation evaluated with transthoracic ultrasound can predict fluid responsiveness in critically ill patients in positive pressure ventilation.
Objective To evaluate if superior vena cava respiratory diameter variation is associated with fluid responsiveness, when compared with the mini fluid infusion of 100ml evaluated with expiratory left ventricle outflow tract velocity time integral (LVOT-VTI) before and after fluid administration.
Methods
After evaluation, inclusion and exclusion criteria checking:
A basal echocardiography is performed, main pattern and clinical data are recorded (age, sex, weight, height, main diagnosis, secondary diagnosis, length of stay, surgical procedures, sequential organ failure assesment (SOFA) score, renal replacement therapy), respiratory (ventilator mode, tidal volume, respiratory rate, positive end expiratory pressure (PEEP), plateau pressure, peak inspiratory pressure, autoPEEP, fraction of inspired oxygen (FiO2), I:E relation, total inspiratory time), hemodynamic data from unit monitors. (cardiac rate, systolic pressure, diastolic pressure, mean pressure, central venous pressure) and closest laboratory to evaluation (lactate, venous oxygen saturation (ScVO2), arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCO2), pH, base excess (BE), bicarbonate (HCO3), carbon dioxide (CO2) arterio-venous difference, )
- Superior vena cava evaluation, Respiratory variation observed in M mode and measured. Registry of expiratory and inspiratory diameter (evaluated in the same cardiac cycle phase)
- Using Apical 5 chamber view, basal LVOT-VTI would be obtained, 3 measurements in regular rhythms and 5 measurements in irregular rhythms such as atrial fibrillation. 100 ml will be infused without changing the view and end-expiratory LVOT-VTI would be obtained a minute after infusion in the same fashion as before.
- Considering ultrasound evaluation is part of standard patient care, informed consent was waived by the ethical board.
- For analysis, the proportion of variation in superior vena cava (SVC) and VTI variation would be calculated as percentage.
- All values will be registered in a google drive table and then included in microsoft excel for coding and analyzed with Stata 12.
- Fluid responsiveness will be defined as 10% increase in VTI with the "mini bolus" fluid test, considering the minimal detectable change.
- For analysis, receiver operator curve (ROC) statistic will be done in Stata 12.
- Summary variables of the population will be presented.
- For diagnostic evaluation, the tool "roctab" for receiver operating characteristic curve will be used, obtaining cut off values, sensitivity, specificity and gray area in addition to traditional area under curve (AUC). A dichotomic value for simple orientation will be selected with an ideally balanced sensitivity and specificity for general use. Linear correlation will be explored to detect a continuous relation between SVC variation and VTI increase.
- Window success will be recorded and proportion will be analysed during the months of the study to check for performance improvements that might be expected as a learning curve effect.
- Additional data might allow post hoc analysis including window feasibility in association with clinical variables and
- After the ultrasound evaluation, the result of the 100ml test will be informed to the treating physician.
- Sample size:
Considering a possible 50% loss with inadequate acoustic window, 100 evaluated patients would achieve at least 48 included to obtain AUC 0.7. (estimating 24 to be responders and 24 not responders)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ventilated critically ill patients with hemodynamic instability hospitalized in the intensive care unit.
Key inclusion criteria (4 listed)
- Patients >18 years,
- Hospitalized in the Intensive Care Unit (ICU) with length of stay under 7 days
- Under positive pressure ventilation with no inspiratory effort,
- With hemodynamic instability (defined as abnormal peripheral perfusion or increased blood lactic or vasopressor infusion of norepinephrine >0.1 ug/kg/min to achieve adequate mean arterial pressure)
Key exclusion criteria (7 listed)
- Spontaneous ventilatory effort
- Lack of venous access
- Carrier of carbapenemase or clostridium difficile
- Lack of adequate superior vena cava (SVC) window (not allowing M-mode during both respiratory phases)
- Severe aortic regurgitation
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 |
|---|---|---|
| Superior vena cava transthoracic evaluationThe superior vena cava will be observed with a cardiac ultrasound machine, its diameter in different respiratory phases evaluated and compared with fluid response. | Diagnostic test | – |
Primary outcome
Fluid responsiveness
Time frame: 1 minute
An increase of 10% or more in the left ventricle velocity time integral value (average of 3 in regular rhythms or 5 in irregular rhythms) measured with cardiac ultrasound in 5 chambers apical view after the infusion of 100ml bolus of intravenous crystalloid solution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 28101605Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
- Background: PubMed 29128963Reuter DA, Chappell D, Perel A. The dark sides of fluid administration in the critically ill patient. Intensive Care Med. 2018 Jul;44(7):1138-1140. doi: 10.1007/s00134-017-4989-4. Epub 2017 Nov 11. No abstract available.
- Background: PubMed 29789983Malbrain MLNG, Van Regenmortel N, Saugel B, De Tavernier B, Van Gaal PJ, Joannes-Boyau O, Teboul JL, Rice TW, Mythen M, Monnet X. Principles of fluid management and stewardship in septic shock: it is time to consider the four D's and the four phases of fluid therapy. Ann Intensive Care. 2018 May 22;8(1):66. doi: 10.1186/s13613-018-0402-x.
- Background: PubMed 26073560Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care. 2015 Jun 15;19(1):251. doi: 10.1186/s13054-015-0970-1.
- Background: PubMed 26162676Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
- Background: PubMed 28817481Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.
- Background: PubMed 27858374Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.
- Background: PubMed 28537997Vistisen ST, Juhl-Olsen P. Where are we heading with fluid responsiveness research? Curr Opin Crit Care. 2017 Aug;23(4):318-325. doi: 10.1097/MCC.0000000000000421.
- Background: PubMed 28708687Michard F. Toward Precision Hemodynamic Management. Crit Care Med. 2017 Aug;45(8):1421-1423. doi: 10.1097/CCM.0000000000002458. No abstract available.
- Background: PubMed 27653798Vignon P, Repesse X, Begot E, Leger J, Jacob C, Bouferrache K, Slama M, Prat G, Vieillard-Baron A. Comparison of Echocardiographic Indices Used to Predict Fluid Responsiveness in Ventilated Patients. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1022-1032. doi: 10.1164/rccm.201604-0844OC.
- Background: PubMed 19237902Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.
- Background: PubMed 26825952Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.
- Individual participant dataSharing planned: Undecided. Probably database will be available if asked once completed.
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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.
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 Shock, run by University of Chile at 1 site in Chile.
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 7 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 29 Nov 2023. 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 Chile. 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 Diego Ugalde, MD (+56974197896, diegougaldecastillo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness (time frame: 1 minute). 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 NCT05211765, which also lists 22 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 29 Nov 2023.