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Completed

NCT Number: NCT02430142

Microcirculatory Oxygen Uptake in Sepsis

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.

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Key information

Conditions

Sepsis Hypoxia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Severe Sepsis Shock Shock, Septic Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Mannheim, 68167, Germany

About this study

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:

  • Is microcirculatory oxygen uptake a prognostic value in sepsis?
  • Is it correlated with biomarkers of hypoxia?
  • Are high levels of ScvO2 caused by microcirculatory impairments or by hyperdynamic macrocirculation?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasoocclusive testing

Other

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

Primary outcomes

  1. Overall Survival

    Time frame: 180 days

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

Secondary outcomes

  1. Connection between ScvO2 and microcirculatory oxygen uptake

    Time frame: Day 1 and day 4

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

  2. Connection between adenosine-metabolites and microcirculatory oxygen uptake

    Time frame: Day 1 and day 4

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

  3. Physical condition

    Time frame: 180 days

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

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Official study title

Microcirculatory Oxygen Uptake in Sepsis, Severe Sepsis and Septic Shock

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 30, 2015
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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