SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study

Study Overview
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Brief Summary
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test for volume responsiveness PiCCO-guided infusion over a pre-defined period of time

Conditions
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Prediction of Volume Responsiveness

Intervention / Treatment
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* Device: PiCCO-parameter-guided volume challenge


Participation Criteria
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Eligibility Criteria
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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: Femoral access of the central venous catheter precluding application of the normal ranges of global enddiastolic volume index and central venous pressure. Absence of sinus rhythm and/or controlled ventilation precluding the use of stroke volume variation. Evidence of increased intraabdominal pressure which is known to further reduce the usefulness of central venous pressure. Contradictory suggestions by stroke volume variation and global enddiastolic volume index. Intolerance of passive leg raising. 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of volume responsiveness using crystalloids<br> | Device: PiCCO-parameter-guided volume challenge<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |