R57.0 R57.2
Conditions
Interventions
Group 1: Standard of care
Group 2: Immediate communication of the additional measured values.
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie Kardiologie I
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All patients with septic or cardiogenic shock who are admitted to our ward and do not meet exclusion criteria will be included in the study and randomised upon admission to the ICU. Since patients in septic or cardiogenic shock in the acute phase of the disease are mostly intubated and sedated, all information will be provided to them as soon as possible. Informed informed consent is obtained only if an informed consent interview is reasonable in the individual case, or a legal guardian/proxy has been appointed who can give consent for the patient. As no additional invasive measures are carried out in the context of the study and the and the apparative diagnostics used consist exclusively of measurements with medical devices within the scope of their approval, subsequent inclusion is possible.
Exclusion criteria
Exclusion criteria: Cutaneous infection focus, burns, pregnant women. Initially, all patients with cardiogenic or septic shock are included who do not meet the above exclusion criteria. The written consent of the patient will be obtained when the patient has passed the acute phase of the disease and is has regained full capacity to consent or a legal guardian has been appointed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patients are either assigned to the Standard of Care Group (Group 1) in which the study doctor collects the data of the additional non-invasive assesment (transcutaneous water loss, skin temperature and PeriFlux laser Doppler) but does not communicate with the doctor on duty, or group 2, in which the documentation of the measured values is available to the doctor on duty. The doctor on duty on each shift completes a questionnaire on subjective assessment of fluid balance, including perceived confidence in their own assessment. It is assesses if the additional information provided by the instrumental procedures represents an additional subjective value. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, on day 10 (after the end of the measurements), all non-invasive instrumental measurements are compared with each other and the measurement of transcutaneous water loss in shock is evaluated as a possible non-invasive measurement parameter for mapping the water balance. | — |
Countries
Germany
Contacts
Public ContactJohannes Wild
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie
Outcome results
None listed