Optimized macro circulation - optimized immune function - optimized outcome

Optimized macro circulation - optimized immune function - optimized outcome - OMOIOO

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010959

Enrollment

100

Registered

2019-07-22

Start date

2016-08-12

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

coronary heart disease, immune dysfunction I24 I25

Interventions

Group 1: Optimized macro hemodynamics based on PiCCO-values (additional to Standard clinical Monitoring (invasive RR, CVP, trans esophageal echocardiography) Group 2: Control Group therapy based on cl

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age > 18 years, indication for CABG (coronary artery bypass graft), Operation time of > 120min, agreement to participate in the study

Exclusion criteria

Exclusion criteria: Non conformity of the inclusion criteria, arrhythmia, pregnancy, inclusion in another invasive study, preoperative infectious disease, Auto immune disease, intake of immune modulatory medication, intake of immune suppresive medication, LVEF 2

Design outcomes

Primary

Measure	Time frame
Immuno dysfunction (measured by flow cytometric measurement of HLA-DR; pre/intra/post operative measurement: pre anaesthesiologic induction, after induction, post CPB, morning after surgery)	—

Secondary

Measure	Time frame
IFN-?, TNF-a, IL-1ß, IL-1RA, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, IL-18, IL-22, HMGB1 active proteasis, endotoxin (LPS), cholin, a-1-antitrypsin(total Protein amount, polymers, cleavage product) TLR2 TLR4 TLR5 production of IL-2, IL-4,IL-6, IL-10, TNF and IFN-? mRNA-expression of inflammosome components (NLRP3, ASC, Pro-Caspase-1) Inflammosome-dependent and independent mediators (pro-IL-1ß, pro-IL-18, IL-6, TNF-a, IL-10) by RT-PCR in periphereal blood mononuclear leucocytes (PBMC) and monocytes Pro-IL-1ß, Pro-Caspase-1, as well asfinished forms IL-1ß, IL-18 major lab values (inclusive CRP, PCT, leukocytes) - age - sex - Body Mass Index CI, SVI, GEDI, SVV, PPV,SVRI, GEF, CFI, CPI, ELWI, MAP, HR, DO2, VO2, avDCO2 - preexisting diseases - pre existing diseases, leading to the stationary admission - length of stay ICU - length of stay hospital - length of stay ventilation - infections - detectedgerms - dieseases since Hospital discharge	—

Measure

Time frame

IFN-?, TNF-a, IL-1ß, IL-1RA, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, IL-18, IL-22, HMGB1 active proteasis, endotoxin (LPS), cholin, a-1-antitrypsin(total Protein amount, polymers, cleavage product) TLR2 TLR4 TLR5 production of IL-2, IL-4,IL-6, IL-10, TNF and IFN-? mRNA-expression of inflammosome components (NLRP3, ASC, Pro-Caspase-1) Inflammosome-dependent and independent mediators (pro-IL-1ß, pro-IL-18, IL-6, TNF-a, IL-10) by RT-PCR in periphereal blood mononuclear leucocytes (PBMC) and monocytes Pro-IL-1ß, Pro-Caspase-1, as well asfinished forms IL-1ß, IL-18 major lab values (inclusive CRP, PCT, leukocytes) - age - sex - Body Mass Index CI, SVI, GEDI, SVV, PPV,SVRI, GEF, CFI, CPI, ELWI, MAP, HR, DO2, VO2, avDCO2 - preexisting diseases - pre existing diseases, leading to the stationary admission - length of stay ICU - length of stay hospital - length of stay ventilation - infections - detectedgerms - dieseases since Hospital discharge

—

Countries

Germany

Contacts

Public ContactChristian Koch

Klinik für Anästhesiologie,Operative Intensivmedizin und Schmerztherapie Universitätsklinikum Giessen und Marburg, Standort Giessen

christian.koch@chiru.med.uni-giessen.de064198444401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026