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Shock, SepticRELASTANCENCT04388267

Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery

An observational study of Shock, Septic and Hyperlactatemia, run by Central Hospital, Nancy, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Septic, Hyperlactatemia, Oliguria
What is being tested?
Fluid challenge
Type of treatment
Injection or infusion
How many people
80 participants
Where
1 siteFrance
Study dates
26 Feb 2019to Jul 2020
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: The study population is a mix of septic shock and patients who underwent elective or emergent major vascular surgery surgery (aortic mostly) requiring a fluid challenge because of hypotension and/or oliguria and/or mottling and/or hyperlactatemia>2mmol/L. All patients will be hospitalized in the surgical intensive care unit (ICU) of the University Hospital of Nancy Brabois, France.

Who may be able to join

  • Age at least 18 years
  • Septic shock (according to Sepsis-3 definition) or patients who underwent elective or emergent abdominal aortic surgery
  • Invasive blood pressure (radial or femoral) and Mostcare monitoring
  • Stroke volume between 20 and 50 mL/beat on the Mostcare system
  • Indication for a fluid challenge: hypotension (Mean arterial pressure under 65mmHg) or oliguria (urine flow rate < 0,5mL/kg/h for more than 12h), mottling, hyperlactatemia > 2 mmol/l

Who cannot join

  • Age <18 years
  • Cardiac arrhythmia
  • Arterial wave form distortion
  • Inappropriate identification of the dicrotic notch for any reason
  • Refuse to consent to the study

Trial locations and contacts

1 site in 1 country.

Philippe Guerci, MD contact

+33 3 83 15 79 95

p.guerci@chru-nancy.fr

Nicolas Dellestable contact

+33 6 18 85 05 26

nico.dellestable@hotmail.fr

France1 site, 1 recruiting

  • CHRU

    Nancy, 54000

    Phillipe Guerci, MD, +33 3 83 15 79 95, p.guerci@chru-nancy.fr

    Recruiting

Other trials in France

About this study

Official title: Comparative Study on the Relationship Between Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or in the Postoperative Course of Aortic Surgery

The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.

The aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery.

Patients will be considered fluid responders if an increase >10% of the stroke volume is observed .

Being tested
Fluid challenge
Keywords
Mostcare, Vascular surgery, Arterial Elastance, Dicrotic pressure, Fluid loading, Pressure Recording Analytical Method, Hemodynamic monitoring, Pulse contour analysis
Medical subject headings
Shock, Septic, Hyperlactatemia, Oliguria, Aortic Aneurysm, Abdominal, Aortic Rupture, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid challengeDrug

    All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe.

    During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion.

    The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.

Study groups in NCT04388267
Study groupRoleWhat they receive
Septic shockPatients with septic shock, according to the Sepsis 3 definition, regardless of the origin
Receives: Drug: Fluid challenge
Major vascular surgeryPatients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery)
Receives: Drug: Fluid challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution of arterial elastance

    Absolute and percentage of change in arterial elastance during the study period

    Measured: 60 minutes

  2. Evolution of Stroke Volume (SV)

    Absolute and percentage of change in stroke volume during the study period

    Measured: 60 minutes

Secondary outcomes (5)

  1. Evolution of Dicrotic Pressure (DP) value during a fluid challenge

    Absolute and percentage of change in dicrotic pressure during the study period

    Measured: 60 minutes

  2. Predictive factors of an increase or a decrease in the arterial elastance value

    Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the arterial elastance

    • epidemiological and clinical: age, BMI, gender, SAPS II, SOFA, Charlson comorbidity index, chronic diseases, etiology of the septic shock, acute kidney injury
    • therapeutical: chronic treatments, vasoactive and sedative drugs, epidural analgesia, mechanical ventilation (VT, RR, PEEP)
    • surgery: type of surgery (open or endovascular), indication, timing.
    • indication for fluid loading: hypotension, oliguria, hyperlactatemia > 2mmol/L, mottling

    Measured: 60 minutes

  3. Predictive factors of an increase or a decrease of the dicrotic pressure value

    Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the dicrotic pressure

    Measured: 60 minutes

  4. Evolution of norepinephrine dose: before and 60 minutes after fluid challenge

    Norepinephrine dose expressed in micrograms per kilogram per minute (μg/kg/min)

    Measured: 60 minutes

  5. All-cause mortality

    30 days all-cause mortality

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2020
  2. Study start26 Feb 2019
  3. Primary completionJun 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

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
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04388267
Sponsor's protocol ID
PSS2018/RELASTANCE-GUERCI/YB
Acronym
RELASTANCE
Status last verified
Jan 2020
First submitted
11 May 2020
Last updated
18 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.

    PubMed 28012725

  • Romagnoli S, Ricci Z, Romano SM, Dimizio F, Bonicolini E, Quattrone D, De Gaudio R. FloTrac/Vigileo(TM) (third generation) and MostCare((R))/PRAM versus echocardiography for cardiac output estimation in vascular surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1114-21. doi: 10.1053/j.jvca.2013.04.017. Epub 2013 Sep 19.

    PubMed 24055563

  • Gopal S, Do T, Pooni JS, Martinelli G. Validation of cardiac output studies from the Mostcare compared to a pulmonary artery catheter in septic patients. Minerva Anestesiol. 2014 Mar;80(3):314-23. Epub 2014 Jan 8.

    PubMed 24398442

  • Messina A, Romano SM, Bonicolini E, Colombo D, Cammarota G, Chiostri M, Della Corte F, Navalesi P, Payen D, Romagnoli S. Cardiac cycle efficiency and dicrotic pressure variations: new parameters for fluid therapy: An observational study. Eur J Anaesthesiol. 2017 Nov;34(11):755-763. doi: 10.1097/EJA.0000000000000661.

    PubMed 28722695

  • Monge Garcia MI, Guijo Gonzalez P, Gracia Romero M, Gil Cano A, Oscier C, Rhodes A, Grounds RM, Cecconi M. Effects of fluid administration on arterial load in septic shock patients. Intensive Care Med. 2015 Jul;41(7):1247-55. doi: 10.1007/s00134-015-3898-7. Epub 2015 Jun 11.

    PubMed 26077088

  • 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 28101605

  • Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10.

    PubMed 18617626

  • Sunagawa K, Maughan WL, Burkhoff D, Sagawa K. Left ventricular interaction with arterial load studied in isolated canine ventricle. Am J Physiol. 1983 Nov;245(5 Pt 1):H773-80. doi: 10.1152/ajpheart.1983.245.5.H773.

    PubMed 6638199

  • Guarracino F, Baldassarri R, Pinsky MR. Ventriculo-arterial decoupling in acutely altered hemodynamic states. Crit Care. 2013 Mar 19;17(2):213. doi: 10.1186/cc12522. No abstract available.

    PubMed 23510336

  • Suga H. Time course of left ventricular pressure-volume relationship under various enddiastolic volume. Jpn Heart J. 1969 Nov;10(6):509-15. doi: 10.1536/ihj.10.509. No abstract available.

    PubMed 5308142

  • Guarracino F, Ferro B, Morelli A, Bertini P, Baldassarri R, Pinsky MR. Ventriculoarterial decoupling in human septic shock. Crit Care. 2014 Apr 24;18(2):R80. doi: 10.1186/cc13842.

    PubMed 24762124

  • Morelli A, Singer M, Ranieri VM, D'Egidio A, Mascia L, Orecchioni A, Piscioneri F, Guarracino F, Greco E, Peruzzi M, Biondi-Zoccai G, Frati G, Romano SM. Heart rate reduction with esmolol is associated with improved arterial elastance in patients with septic shock: a prospective observational study. Intensive Care Med. 2016 Oct;42(10):1528-1534. doi: 10.1007/s00134-016-4351-2. Epub 2016 Apr 21.

    PubMed 27101380

  • Walley KR. Left ventricular function: time-varying elastance and left ventricular aortic coupling. Crit Care. 2016 Sep 10;20(1):270. doi: 10.1186/s13054-016-1439-6.

    PubMed 27613430

  • Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.

    PubMed 29019850

Questions about this trial

What is this clinical trial studying?

An observational study of Shock, Septic and Hyperlactatemia, run by Central Hospital, Nancy, France at 1 site in France.

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 5 inclusion and 5 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 18 May 2020. 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 France. 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 Philippe Guerci, MD (+33 3 83 15 79 95, p.guerci@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of arterial elastance (time frame: 60 minutes). The study lists 2 primary outcomes in all. 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 NCT04388267, which also lists 14 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 18 May 2020.

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