Microcirculatory Oxygen Uptake in Sepsis

NCT02430142 | Completed

• 1 other identifier: 2014-428M-MA
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for prognostic value and for associations with tissue hypoxia markers and high central venus saturations.

Conditions

Sepsis; Severe Sepsis; Septic Shock

Keywords

microcirculation; oxygen uptake; hypoxia; adenosine; central venous saturation; hypoxanthine; laserdoppler

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  ICU-Mortality, 60-days-mortlity, 180-days-mortality will be recorded and correlated with baseline and postischemic microcirculatory oxygen delivery and uptake.

  180 days

Secondary Outcomes (3)

• Connection between ScvO2 and microcirculatory oxygen uptake

  Day 1 and day 4

• Connection between adenosine-metabolites and microcirculatory oxygen uptake

  Day 1 and day 4

• Physical condition

  180 days

Study Arms (3)

Vasoocclusive testing in sepsis

Septic patients defined according to the Surviving Sepsis Campaign (SSC)

Other: Vasoocclusive testing

Vasoocclusive testing in severe sepsis

Severe septic patients defined according to the Surviving Sepsis Campaign (SSC)

Other: Vasoocclusive testing

Vasoocclusive testing in sepsic shock

Septic shock patients defined according to the Surviving Sepsis Campaign (SSC)

Other: Vasoocclusive testing

Interventions

Vasoocclusive testing OTHER

Forearm vasoocclusive testing with a laser-doppler spectrophotometry system, transpulmonary thermodilution and blood sampling;

Vasoocclusive testing in sepsic shock; Vasoocclusive testing in sepsis; Vasoocclusive testing in severe sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted a surgical intensive care unit within the last 24 hours and the diagnosis of sepsis, severe sepsis and septic shock according to the Surviving Sepsis Campaign.

You may qualify if:

• Criteria according to the SSC for sepsis, severe sepsis and septic shock
• Admission to the ICU within 24 hours

You may not qualify if:

• Pregnancy
• Cardiopulmonary resuscitation within the last 5 days

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

University Medical Centre, Department of Anaesthesiology and Surgical Intensive Care Medicine

Mannheim, 68167, Germany

Location

Related Publications (7)

• Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.

  PMID: 23984731 BACKGROUND

• De Backer D, Donadello K, Cortes DO. Monitoring the microcirculation. J Clin Monit Comput. 2012 Oct;26(5):361-6. doi: 10.1007/s10877-012-9383-8. Epub 2012 Jul 26.

  PMID: 22833180 BACKGROUND

• Shapiro NI, Arnold R, Sherwin R, O'Connor J, Najarro G, Singh S, Lundy D, Nelson T, Trzeciak SW, Jones AE; Emergency Medicine Shock Research Network (EMShockNet). The association of near-infrared spectroscopy-derived tissue oxygenation measurements with sepsis syndromes, organ dysfunction and mortality in emergency department patients with sepsis. Crit Care. 2011;15(5):R223. doi: 10.1186/cc10463. Epub 2011 Sep 22.

  PMID: 21939529 BACKGROUND

• Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.

  PMID: 15343008 BACKGROUND

• Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

  PMID: 23353941 BACKGROUND

• Textoris J, Fouche L, Wiramus S, Antonini F, Tho S, Martin C, Leone M. High central venous oxygen saturation in the latter stages of septic shock is associated with increased mortality. Crit Care. 2011 Jul 26;15(4):R176. doi: 10.1186/cc10325.

  PMID: 21791065 BACKGROUND

• van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126.

  PMID: 25032942 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Hypoxia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Manfred Thiel, Prof. Dr. med.

  Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre of Mannheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Timo Sturm, DESA

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 30, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: August 1, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-05

Locations

DE (1)