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SepsisNCT02430142

Microcirculatory Oxygen Uptake in Sepsis

An observational study of Sepsis and Severe Sepsis, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Severe Sepsis, Septic Shock
What is being tested?
Vasoocclusive testing
How many people
102 participants
Where
1 siteGermany
Study dates
Apr 2015to 1 Aug 2017
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: 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.

Who may be able to join

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

Who cannot join

  • Pregnancy
  • Cardiopulmonary resuscitation within the last 5 days

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Mannheim, 68167

Other trials in Germany

About this study

Official title: Microcirculatory Oxygen Uptake in Sepsis, Severe Sepsis and Septic Shock

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.

Read the detailed description

Sepsis remains a common entity in critical care patients with remarkable mortality. Microcirculatory dysfunction plays a pivotal role in the pathophysiology of sepsis and organ dysfunction. The main causal mechanisms are vasoactive substances such as nitric oxide and endothelin, destroyed endothelial surfaces and microvascular occlusion by activated coagulation and leucocytes. Furthermore there is some knowledge from vasooclussive testing (VOT) based on near-infrared spectroscopy (NIRS) and assessing the proportion of perfused vessels determined with orthogonal polarization spectral and sidestream darkfield imaging techniques (SDF) that impaired microcirculation is associated with organ dysfunction and increased mortality. Despite these well-recognised evidence previous trails proving therapy guidance with microcirculatory parameters failed in demonstrating optimised outcome . Recent guidelines still recommend fluid therapy based on central venous pressure, mean arterial pressure, urine output and or blood lactate concentration. But especially the parameter central venous oxygen saturation (ScvO2) seems to be not unproblematic. Retrospective data analysis found higher mortality rates if ScvO2 is elevated.

In the present study patients with sepsis, severe sepsis and septic shock will be evaluated on day 1 and day 4 and a follow up will be performed on day 180.

Additional to clinical parameters of organ function, infection markers, global parameters of tissue hypoxia will be captured by measurements of adenosine and whose metabolites.

Macrocirculatory cardiovascular function delivered by transpulmonary thermodilution technique will be assessed and local tissue perfusion and oxygen uptake will be measured with a transcutaneous laser-doppler spectrophotometry system in VOT.

The aim of this study is to check:

  1. Is microcirculatory oxygen uptake a prognostic value in sepsis?
  2. Is it correlated with biomarkers of hypoxia?
  3. Are high levels of ScvO2 caused by microcirculatory impairments or by hyperdynamic macrocirculation?
Being tested
Vasoocclusive testing
Keywords
microcirculation, oxygen uptake, hypoxia, adenosine, central venous saturation, hypoxanthine, laserdoppler
Medical subject headings
Sepsis, Shock, Septic, Hypoxia

What participants receive

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

  • Vasoocclusive testingOther

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

Study groups in NCT02430142
Study groupRoleWhat they receive
Vasoocclusive testing in sepsisSeptic patients defined according to the Surviving Sepsis Campaign (SSC)
Receives: Other: Vasoocclusive testing
Vasoocclusive testing in severe sepsisSevere septic patients defined according to the Surviving Sepsis Campaign (SSC)
Receives: Other: Vasoocclusive testing
Vasoocclusive testing in sepsic shockSeptic shock patients defined according to the Surviving Sepsis Campaign (SSC)
Receives: Other: Vasoocclusive testing

What is being measured

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

  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.

    Measured: 180 days

Secondary outcomes (3)

  1. Connection between ScvO2 and microcirculatory oxygen uptake

    The investigators will prove, if high values of central venous saturation (>75%) are associated with impaired tissue oxygen uptake.

    Measured: Day 1 and day 4

  2. Connection between adenosine-metabolites and microcirculatory oxygen uptake

    The investigators will prove, if high values of the adenosine-metabolite hypoxanthine (ng/ml) in plasma are associated with impaired tissue oxygen uptake.

    Measured: Day 1 and day 4

  3. Physical condition

    Physical status at 180 days (Rankin-Scale) will be recorded and correlated with baseline and postischemic microcirculatory oxygen delivery and uptake.

    Measured: 180 days

Timeline

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

  1. First posted30 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2016
  4. Study completion1 Aug 2017

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
Cohort
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02430142
Sponsor's protocol ID
2014-428M-MA
Status last verified
May 2018
First submitted
16 Apr 2015
Last updated
2 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23984731

  • 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.

    PubMed 22833180

  • 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.

    PubMed 21939529

  • 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.

    PubMed 15343008

  • 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.

    PubMed 23353941

  • 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.

    PubMed 21791065

  • 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.

    PubMed 25032942

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Severe Sepsis, run by Universitätsmedizin Mannheim at 1 site in Germany.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 May 2018. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 180 days). 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 NCT02430142, which also lists 7 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 2 May 2018.

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