Trial document
This trial has been registered retrospectively.
DRKS00003327
Trial Description
Title
Cerebral near infrared spectroscopy for prediction of central desaturation in sepsis
Trial Acronym
NIRSep
URL of the Trial
[---]*
Brief Summary in Lay Language
The study examines the possibility of monitoring centralvenous saturation of patients with sepsis by using an optical method to estimate the near-infrared spectroscopy. This value is used to monitor the circulatory function of critically ill patients.
Brief Summary in Scientific Language
Hemodynamic optimization is an important component in early and targeted sepsis therapy. Central venous saturation is one of the defined target values in this context, the. The aim of this study is to investigate the relationship between ScvO2 and frontalzerebralen local Near-infrared spectoscopie in surgical patients in intensive care with septic disease.
Organizational Data
- DRKS00003327
- 2013/03/12
- [---]*
- yes
- Approved
- 57/12, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
Secondary IDs
- [---]*
Health Condition or Problem studied
- A41.9 - Sepsis, unspecified
Interventions/Observational Groups
- Sepsis. Patients with a septic syndrome. Relationship between central venous saturation and local cerebral near-infrared spectoscopie.
Characteristics
- Non-interventional
- Other
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Diagnostic
- Single (group)
- N/A
- N/A
Primary Outcome
Fontal near-infrared spectroscopy measured on the forehead and on the base of the left thumb at Admission/24h later / 48h later for the predication of central venous saturation measured in the BGA derived from central venous blood of ICU patients with septic syndromes
Secondary Outcome
Arterial and venous lactate concentration measured , SaO2 in BGA, Blood pressure (measured invasively), catecholamines, PaO2 (in BGA), ventilation mode, ventilation parameters, FiO2, CVP, cardiac output, cardiac index, Peripheral Resistance (measured by pulse contour analysis)
Fontal near-infrared spectroscopy measured on the forehead and at the base of the left thumb at admission/24h later / 48h later for the predication of central venous saturation measured in the BGA derived from central venous blood of ICU patients with septic syndromes
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2012/06/27
- 50
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Sepsis diagnosed for less than 4 hours,
Age> 18 years, intensive care treatment
Exclusion Criteria
apoplexy,
Intracerebral hemorrhage,
Patients aged <18 years,
Participation in another interventional study
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Gießen Klinik für Anästhesieologie und Operative Intensivmedizin
- Mr. Prof. Dr. med. Markus A. Weigand
- Rudolph-Buchheim-Str. 7
- 35394 Gießen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 064198544401
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Gießen Klinik für Anästhesieologie und Operative Intensivmedizin
- Mr. Christian Koch
- Rudolph-Buchheim-Str.7
- 35394 Gießen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 064198556622
- [---]*
- christian.koch at chiru.med.uni-giessen.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- UKGM Standort Gießen Abteilung für Anaesthesiologie, Operative Intensivmedizin und Schmerztherapie
- Mr. Christian Koch
- Rudolf-Buchheim-Str. 7
- 35392 Gießen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0641-98556622
- 0641-98544407
- christian.koch at chiru.med.uni-giessen.de
- http://www.ukgm.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Abteilung für Anaesthesiologie, Operative Intensivmedizin und Schmerztherapie
- Mr. Prof. Dr. Markus Weigand
- Rudolf-Buchheim-Str. 7
- 35392 Gießen
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0641-98544401
- 0641-98544409
- markus.weigand at chiru.med.uni-giessen.de
- http://www.ukgm.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
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