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Microcirculatory Oxygen Uptake in Sepsis

U

Universitätsmedizin Mannheim

Status

Completed

Conditions

Severe Sepsis
Septic Shock
Sepsis

Treatments

Other: Vasoocclusive testing

Study type

Observational

Funder types

Other

Identifiers

NCT02430142
2014-428M-MA

Details and patient eligibility

About

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.

Full 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?

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Cardiopulmonary resuscitation within the last 5 days

Trial design

102 participants in 3 patient groups

Vasoocclusive testing in sepsis
Description:
Septic patients defined according to the Surviving Sepsis Campaign (SSC)
Treatment:
Other: Vasoocclusive testing
Vasoocclusive testing in severe sepsis
Description:
Severe septic patients defined according to the Surviving Sepsis Campaign (SSC)
Treatment:
Other: Vasoocclusive testing
Vasoocclusive testing in sepsic shock
Description:
Septic shock patients defined according to the Surviving Sepsis Campaign (SSC)
Treatment:
Other: Vasoocclusive testing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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