Volemic Resuscitation in Sepsis and Septic Shock
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 14, 2016
December 1, 2016
2 years
September 1, 2015
December 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue perfusion at six hours (composite)
Tissue perfusion at six hours: urinary output, blood pressure, lactate clearance, skin aspect
six hours
Secondary Outcomes (6)
Duration of cardiovascular failure
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
Duration of acute renal failure
at 5 days, at 10 days, at 30 days and at 60 days
Duration of ICU stay and in hospital stay
status at 5 days, at 10 days, at 30 days and at 60 days
Discharge status at 60 days
at 60 days
- +1 more secondary outcomes
Study Arms (4)
Sepsis grup 1
EXPERIMENTALFlotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours
Sepsis grup 2
EXPERIMENTALHemodymanic 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
EXPERIMENTALFlotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours
Soc septic grup 2
EXPERIMENTALHemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours andVolumeView/Ev1000 monitoring during the next 4 hours
Interventions
Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours
Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cluj County Emenrgency Hospital
Cluj-Napoca, Cluj, 400006, Romania
Related Publications (11)
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.
PMID: 24635774RESULTARISE 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.
PMID: 25272316RESULTMouncey 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.
PMID: 25776532RESULTRussell 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.
PMID: 24635771RESULTAsfar 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.
PMID: 24635770RESULTBakker 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.
PMID: 23663301RESULTCecconi 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.
PMID: 24280808RESULTCecconi 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.
PMID: 20096600RESULTMonnet 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.
PMID: 20537159RESULTMarque 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.
PMID: 23361128RESULTAntonelli 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.
PMID: 17285286RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Antal Oana MD
Study Record Dates
First Submitted
September 1, 2015
First Posted
October 1, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
December 14, 2016
Record last verified: 2016-12