Microcirculatory Oxygen Uptake in Sepsis

Completed

• Conditions: Severe Sepsis; Sepsis; Septic Shock
• Interventions: Other: Vasoocclusive testing

• Registration Number: NCT02430142
• Lead Sponsor: Universitätsmedizin Mannheim

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?

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-25
• Study First Posted: 2015-04-30
• Primary Completion: 2016-10
• Study Completion: 2017-08-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Survival	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 Outcome Measures

Name	Time	Method
Physical condition	180 days	Physical status at 180 days (Rankin-Scale) will be recorded and correlated with baseline and postischemic microcirculatory oxygen delivery and uptake.
Connection between ScvO2 and microcirculatory oxygen uptake	Day 1 and day 4	The 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 uptake	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.

Trial Locations

Locations (1)

University Medical Centre, Department of Anaesthesiology and Surgical Intensive Care Medicine; 🇩🇪 Mannheim, Germany