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Microcirculatory Oxygen Uptake in Sepsis

Microcirculatory Oxygen Uptake in Sepsis, Severe Sepsis and Septic Shock

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02430142
Enrollment
102
Registered
2015-04-30
Start date
2015-04-30
Completion date
2017-08-01
Last updated
2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock, Severe Sepsis

Keywords

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

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.

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?

Interventions

OTHERVasoocclusive testing

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

Sponsors

Universitätsmedizin Mannheim
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival180 daysICU-Mortality, 60-days-mortlity, 180-days-mortality will be recorded and correlated with baseline and postischemic microcirculatory oxygen delivery and uptake.

Secondary

MeasureTime frameDescription
Connection between ScvO2 and microcirculatory oxygen uptakeDay 1 and day 4The investigators will prove, if high values of central venous saturation (\>75%) are associated with impaired tissue oxygen uptake.
Connection between adenosine-metabolites and microcirculatory oxygen uptakeDay 1 and day 4The investigators will prove, if high values of the adenosine-metabolite hypoxanthine (ng/ml) in plasma are associated with impaired tissue oxygen uptake.
Physical condition180 daysPhysical status at 180 days (Rankin-Scale) will be recorded and correlated with baseline and postischemic microcirculatory oxygen delivery and uptake.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026