Microcirculatory Oxygen Uptake in Sepsis

NCT ID: NCT02430142

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-08-01

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?

Conditions

Sepsis; Severe Sepsis; Septic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vasoocclusive testing in sepsis

Septic patients defined according to the Surviving Sepsis Campaign (SSC)

Vasoocclusive testing

Intervention Type: OTHER

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

Vasoocclusive testing in severe sepsis

Severe septic patients defined according to the Surviving Sepsis Campaign (SSC)

Vasoocclusive testing

Intervention Type: OTHER

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

Vasoocclusive testing in sepsic shock

Septic shock patients defined according to the Surviving Sepsis Campaign (SSC)

Vasoocclusive testing

Intervention Type: OTHER

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

Interventions

Vasoocclusive testing

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Timo Sturm

Dr. med. Timo Sturm, DESA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manfred Thiel, Prof. Dr. med.

Role: STUDY_CHAIR

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

Locations

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

Mannheim, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 23984731 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22833180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21939529 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15343008 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23353941 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21791065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25032942 (View on PubMed)

Other Identifiers

2014-428M-MA

Identifier Type: -

Identifier Source: org_study_id