patients with multiorgan dysfunction syndrome (MODS)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - patients with multiorgan dysfunction syndrome (APACHE II Score >= 20 to <=35) hospitalized in intensive care unit - indiction for haemodynamic monitoring independetn on study - written informed consent or suspected will of patient for participation on study - diagnosis of multiorgan dysfunction syndrome <= 24 h
Exclusion criteria
Exclusion criteria: - patients younger then 18 years - pregnancy, lactation - patients with malignant hyperthermia - patients with transplantation of cell, bone marrow, stem cell or organ - paricipation in other studies within last 3 months - patients with whish for limitation or discontinuation of therapy either directly or suspected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| microcirculation measured with sidestream-dark-field measurement Measurements will be performed 5 minutes before and 5 minutes after each treatment with BEMER as well as between tretaments (also for 5 minutes) (s. brief summary in scientific language) | — |
Secondary
| Measure | Time frame |
|---|---|
| Every day of treatment all secondary objectives will be exmined. Exact timepoints of examination are listed below. 1) changing severity of multiorgan dysfunction syndrome (APACHE II Score) and changing coagulation (ISTH Overt DIC Score) timepoint 0h and 8 h 2) changin in cardiavascular parameters a) Heartindex (HI), Cardiac Power-Index (CPI), Afterloadrelated Cardiac Performance (ACP), systemic vessel resistance (SVR) timepoint: before and after treatment with BEMER and between treatments; parellel to SDF-Measurement b) cumulative dose of vasopressors timepoint: 0h, retrospective last 12 h c) serum lactat timepoint: 0h and 8h 3) changin in cardial autonomous function (cardiac frequency, heart rate variability) timepoint: before and after treatment with BEMER and between treatments, parellel to SDF-Measurement 4) safety of patients (adverse events, device deficiencies) continuous 5) lethality (intensive care unit, hospital, 28 d and 180 d after beginning of therapy) | — |
Countries
Germany
Contacts
Universitätsklinikum Halle