Hemodynamic InstabilityNCT02565251
Volemic Resuscitation in Sepsis and Septic Shock
A study testing Flotrac/Ev1000, Standard ICU monitorisation and VolumeView/Ev1000 in people with Hemodynamic Instability and Sepsis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemodynamic Instability, Sepsis, Septic Shock
- What is being tested?
- Flotrac/Ev1000, Standard ICU monitorisation and VolumeView/Ev1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- Sep 2015to Sep 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- age less then 18 and more then 85 cardiac valvular pathology with hemodynamic importance cardiac failure NYHA IV primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology Severe liver failure (Child-Pugh C) Anuric renal failure Pregnant women Patient who refuse blood products adminitration End-stage cancer
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Cluj County Emenrgency Hospital
Cluj-Napoca, Cluj, 400006
Natalia Hagau, Professor, 0742272385, hagaunatalia@gmail.com
About this study
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.
The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks.
The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.
Read the detailed description
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe . Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.
The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks. The persistence of hypotension after adequate fluid load is the result of low vascular resistance and myocardial dysfunction and calls for certain specific correctional measures.
The diffrent hemodynamic profiles which can be found in the different stages of the septic shock and their dificult clinical identification led to the development of varoius hemodynamic monitoring techniques and devices. These techniques can be classified into invasive and minimally invasive, calibrated and uncalibrated. The major diffrences among these tecniques is the easyness of utilisation and the acuracy of the data obtained.
Inclusion Criteria: severe sepsis and septic shock (acording to the Sepsis Campaign 2013 crieria) patients with medical or surgical pathology which are admitted in the ICU unit in the first six hours after the onset of the severe sepsis/septic shock. The exclusion criteria of the patients are age less then 18 and more then 75, cardiac valvular pathology with hemodynamic importance, cardiac failure NYHA III și IV, primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology,severe liver failure (Child-Pugh C), anuric renal failure, pregnant women, patient who refuse blood products adminitration, end-stage cancer.
The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.
The primary outcome is the adecuacy of tissue perfusion at six hours (urinary output, blood pressure, lactate clearance, skin aspect). The secondary oucomes are duration of cardiovascular failure at the end of the 6 hours resuscitation period/ number of days, duration of respiratory failure (need of mechanical ventilation, number of days), duration of acute renal failure (need of dialysis) at ICU discharge/10/30/60 days, duration of ICU stay and in hospital stay, discharge status at 60 days (not discharged ,discharge to another acute care hospital, discharged to nursing home, discharged home ,other or unknown and all cause mortality at 60 days.
- Conditions
- Hemodynamic Instability, Sepsis, Septic Shock
- Being tested
- Flotrac/Ev1000, Standard ICU monitorisation, VolumeView/Ev1000
- Keywords
- sepsis, hemodynamic monitoring, septic shock, volemic resuscitation, fluid resuscitation
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotrac/Ev1000Device
Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours
Standard ICU monitorisationDevice
Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours
VolumeView/Ev1000Device
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
| Study group | Role | What they receive |
|---|---|---|
| Sepsis grup 1 | Experimental | Flotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours Receives: Device: Flotrac/Ev1000; Device: VolumeView/Ev1000 |
| Sepsis grup 2 | Experimental | Hemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours Receives: Device: Standard ICU monitorisation; Device: VolumeView/Ev1000 |
| Soc septic grup 1 | Experimental | Flotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours Receives: Device: Flotrac/Ev1000; Device: VolumeView/Ev1000 |
| Soc septic grup 2 | Experimental | Hemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours andVolumeView/Ev1000 monitoring during the next 4 hours Receives: Device: Standard ICU monitorisation; Device: VolumeView/Ev1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue perfusion at six hours (composite)
Tissue perfusion at six hours: urinary output, blood pressure, lactate clearance, skin aspect
Measured: six hours
Secondary outcomes (6)
Duration of cardiovascular failure
need of vasopressor support: at the end of the 6 hours resuscitation period and one, two, six and twelve days
Measured: at the end of the 6 hours resuscitation period and one, two, six and twelve days
Duration of respiratory failure
respiratory failure at oane day, two days, six days and twelve days
Measured: respiratory failure at oane day, two days, six days and twelve days
Duration of acute renal failure
Duration of acute renal failure (need of dialysis) at 5 days, at 10 days, at 30 days and at 60 days
Measured: at 5 days, at 10 days, at 30 days and at 60 days
Duration of ICU stay and in hospital stay
Duration of ICU stay and in hospital stay
Measured: status at 5 days, at 10 days, at 30 days and at 60 days
Discharge status at 60 days
Discharge status at 60 days:Not discharged ,Discharge to another acute care hospital,Discharged to nursing home,Discharged home ,Other or unknown
Measured: at 60 days
all cause mortality at 60 days
all cause mortality at 60 days
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Platon Oana, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565251
- Sponsor's protocol ID
- FWA00022929
- Status last verified
- Dec 2016
- First submitted
- 1 Sep 2015
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lilly CM. The ProCESS trial--a new era of sepsis management. N Engl J Med. 2014 May 1;370(18):1750-1. doi: 10.1056/NEJMe1402564. Epub 2014 Mar 18. No abstract available.
PubMed 24635774ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
PubMed 25272316Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.
PubMed 25776532Russell JA. Is there a good MAP for septic shock? N Engl J Med. 2014 Apr 24;370(17):1649-51. doi: 10.1056/NEJMe1402066. Epub 2014 Mar 18. No abstract available.
PubMed 24635771Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
PubMed 24635770Bakker J, Nijsten MW, Jansen TC. Clinical use of lactate monitoring in critically ill patients. Ann Intensive Care. 2013 May 10;3(1):12. doi: 10.1186/2110-5820-3-12.
PubMed 23663301Cecconi M, Arulkumaran N, Kilic J, Ebm C, Rhodes A. Update on hemodynamic monitoring and management in septic patients. Minerva Anestesiol. 2014 Jun;80(6):701-11. Epub 2013 Nov 26.
PubMed 24280808Cecconi M, Hofer C, Della Rocca G, Grounds RM, Rhodes A. Assessing agreement in cardiac output monitoring validation studies. J Cardiothorac Vasc Anesth. 2010 Aug;24(4):741; author reply 741-2. doi: 10.1053/j.jvca.2009.11.008. Epub 2010 Jan 22. No abstract available.
PubMed 20096600Monnet X, Anguel N, Naudin B, Jabot J, Richard C, Teboul JL. Arterial pressure-based cardiac output in septic patients: different accuracy of pulse contour and uncalibrated pressure waveform devices. Crit Care. 2010;14(3):R109. doi: 10.1186/cc9058. Epub 2010 Jun 10.
PubMed 20537159Marque S, Gros A, Chimot L, Gacouin A, Lavoue S, Camus C, Le Tulzo Y. Cardiac output monitoring in septic shock: evaluation of the third-generation Flotrac-Vigileo. J Clin Monit Comput. 2013 Jun;27(3):273-9. doi: 10.1007/s10877-013-9431-z. Epub 2013 Jan 30.
PubMed 23361128Antonelli M, Levy M, Andrews PJ, Chastre J, Hudson LD, Manthous C, Meduri GU, Moreno RP, Putensen C, Stewart T, Torres A. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive Care Med. 2007 Apr;33(4):575-90. doi: 10.1007/s00134-007-0531-4.
PubMed 17285286
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volemic Resuscitation in Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT02565251
- Acronym / sponsor ID
- FWA00022929
- Conditions
- Hemodynamic Instability, Sepsis, Septic Shock
- Keywords
- sepsis, hemodynamic monitoring, septic shock, volemic resuscitation, fluid resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- 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.
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.
The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks.
The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.
Detailed description
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe . Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.
The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks. The persistence of hypotension after adequate fluid load is the result of low vascular resistance and myocardial dysfunction and calls for certain specific correctional measures.
The diffrent hemodynamic profiles which can be found in the different stages of the septic shock and their dificult clinical identification led to the development of varoius hemodynamic monitoring techniques and devices. These techniques can be classified into invasive and minimally invasive, calibrated and uncalibrated. The major diffrences among these tecniques is the easyness of utilisation and the acuracy of the data obtained.
Inclusion Criteria: severe sepsis and septic shock (acording to the Sepsis Campaign 2013 crieria) patients with medical or surgical pathology which are admitted in the ICU unit in the first six hours after the onset of the severe sepsis/septic shock. The exclusion criteria of the patients are age less then 18 and more then 75, cardiac valvular pathology with hemodynamic importance, cardiac failure NYHA III și IV, primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology,severe liver failure (Child-Pugh C), anuric renal failure, pregnant women, patient who refuse blood products adminitration, end-stage cancer.
The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.
The primary outcome is the adecuacy of tissue perfusion at six hours (urinary output, blood pressure, lactate clearance, skin aspect). The secondary oucomes are duration of cardiovascular failure at the end of the 6 hours resuscitation period/ number of days, duration of respiratory failure (need of mechanical ventilation, number of days), duration of acute renal failure (need of dialysis) at ICU discharge/10/30/60 days, duration of ICU stay and in hospital stay, discharge status at 60 days (not discharged ,discharge to another acute care hospital, discharged to nursing home, discharged home ,other or unknown and all cause mortality at 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sepsis grup 1 | Experimental | Device: Flotrac/Ev1000, Device: VolumeView/Ev1000Flotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours |
| Sepsis grup 2 | Experimental | Device: Standard ICU monitorisation, Device: VolumeView/Ev1000Hemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours |
| Soc septic grup 1 | Experimental | Device: Flotrac/Ev1000, Device: VolumeView/Ev1000Flotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours |
| Soc septic grup 2 | Experimental | Device: Standard ICU monitorisation, Device: VolumeView/Ev1000Hemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours andVolumeView/Ev1000 monitoring during the next 4 hours |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- age less then 18 and more then 85 cardiac valvular pathology with hemodynamic importance cardiac failure NYHA IV primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology Severe liver failure (Child-Pugh C) Anuric renal failure Pregnant women Patient who refuse blood products adminitration End-stage cancer
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 |
|---|---|---|
| Flotrac/Ev1000Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours | Device | Sepsis grup 1, Soc septic grup 1 |
| Standard ICU monitorisationHemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours | Device | Sepsis grup 2, Soc septic grup 2 |
| VolumeView/Ev1000Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours | Device | Sepsis grup 1, Sepsis grup 2, Soc septic grup 1, Soc septic grup 2 |
Primary outcome
Tissue perfusion at six hours (composite)
Time frame: six hours
Tissue perfusion at six hours: urinary output, blood pressure, lactate clearance, skin aspect
6 secondary outcomes
Duration of cardiovascular failure
Time frame: at the end of the 6 hours resuscitation period and one, two, six and twelve days
Duration of respiratory failure
Time frame: respiratory failure at oane day, two days, six days and twelve days
Duration of acute renal failure
Time frame: at 5 days, at 10 days, at 30 days and at 60 days
Duration of ICU stay and in hospital stay
Time frame: status at 5 days, at 10 days, at 30 days and at 60 days
Discharge status at 60 days
Time frame: at 60 days
all cause mortality at 60 days
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Results publication: PubMed 24635774Lilly CM. The ProCESS trial--a new era of sepsis management. N Engl J Med. 2014 May 1;370(18):1750-1. doi: 10.1056/NEJMe1402564. Epub 2014 Mar 18. No abstract available.
- Results publication: PubMed 25272316ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
- Results publication: PubMed 25776532Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.
- Results publication: PubMed 24635771Russell JA. Is there a good MAP for septic shock? N Engl J Med. 2014 Apr 24;370(17):1649-51. doi: 10.1056/NEJMe1402066. Epub 2014 Mar 18. No abstract available.
- Results publication: PubMed 24635770Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
- Results publication: PubMed 23663301Bakker J, Nijsten MW, Jansen TC. Clinical use of lactate monitoring in critically ill patients. Ann Intensive Care. 2013 May 10;3(1):12. doi: 10.1186/2110-5820-3-12.
- Results publication: PubMed 24280808Cecconi M, Arulkumaran N, Kilic J, Ebm C, Rhodes A. Update on hemodynamic monitoring and management in septic patients. Minerva Anestesiol. 2014 Jun;80(6):701-11. Epub 2013 Nov 26.
- Results publication: PubMed 20096600Cecconi M, Hofer C, Della Rocca G, Grounds RM, Rhodes A. Assessing agreement in cardiac output monitoring validation studies. J Cardiothorac Vasc Anesth. 2010 Aug;24(4):741; author reply 741-2. doi: 10.1053/j.jvca.2009.11.008. Epub 2010 Jan 22. No abstract available.
- Results publication: PubMed 20537159Monnet X, Anguel N, Naudin B, Jabot J, Richard C, Teboul JL. Arterial pressure-based cardiac output in septic patients: different accuracy of pulse contour and uncalibrated pressure waveform devices. Crit Care. 2010;14(3):R109. doi: 10.1186/cc9058. Epub 2010 Jun 10.
- Results publication: PubMed 23361128Marque S, Gros A, Chimot L, Gacouin A, Lavoue S, Camus C, Le Tulzo Y. Cardiac output monitoring in septic shock: evaluation of the third-generation Flotrac-Vigileo. J Clin Monit Comput. 2013 Jun;27(3):273-9. doi: 10.1007/s10877-013-9431-z. Epub 2013 Jan 30.
- Results publication: PubMed 17285286Antonelli M, Levy M, Andrews PJ, Chastre J, Hudson LD, Manthous C, Meduri GU, Moreno RP, Putensen C, Stewart T, Torres A. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive Care Med. 2007 Apr;33(4):575-90. doi: 10.1007/s00134-007-0531-4.
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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?
A study testing Flotrac/Ev1000, Standard ICU monitorisation and VolumeView/Ev1000 in people with Hemodynamic Instability and Sepsis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 0 inclusion and 1 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 14 Dec 2016. 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 Romania. 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 Natalia Hagau, Professor (0742272385, hagaunatalia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue perfusion at six hours (composite) (time frame: six hours). 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 NCT02565251, which also lists 11 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 14 Dec 2016.