Prediction of Volume Responsiveness
Conditions
Brief summary
* test for volume responsiveness * PiCCO-guided infusion over a pre-defined period of time
Interventions
DEVICEPiCCO-parameter-guided volume challenge
Infusion of 7ml/kg crystalloid over 30 minutes, Performing transpulmonary thermodilutions after 0min, 15min and 30min. Recording of pulse contour cardiac index, heart rate and mean arterial pressure after 5, 10, 15, 20, 25 and 30min. Catecholamines are kept stable over the 30min period.
Sponsors
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are equipped with PiCCO monitoring independently to the study. * One criteria of decreased usefulness of the parameters of preload/volume responsiveness available using the PiCCO device: 1. Femoral access of the central venous catheter precluding application of the normal ranges of global enddiastolic volume index and central venous pressure. 2. Absence of sinus rhythm and/or controlled ventilation precluding the use of stroke volume variation. 3. Evidence of increased intraabdominal pressure which is known to further reduce the usefulness of central venous pressure. 4. Contradictory suggestions by stroke volume variation and global enddiastolic volume index. 5. Intolerance of passive leg raising. 6. Absence of therapeutic alternatives to volume resuscitation.
Exclusion criteria
* Extravascular volume-over plus: global enddiastolic volume index \> 1000ml/sqm * Pulmonary edema: extravascular lungwater index \> 20ml/kg * Cardiogenic shock without volume deficiency (cardiac index \<2L/min; global enddiastolic volume index \> 850ml/sqm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 15 minutes | 15 minutes after start of infusion |
| Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 30 minutes | 30 minutes after start of infusion |
Secondary
| Measure | Time frame |
|---|---|
| Predictive capabilities of Cardiac Index (measured by pulse contour) | within 30 minutes after start of infusion |
| Comparison of global enddiastolic volume index to baseline values | 30 minutes after start of infusion |
| Comparison of central venous pressure levels to baseline values | 30 minutes after start of infusion |
Countries
Germany
Outcome results
None listed