Status:
UNKNOWN
SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
Lead Sponsor:
Technical University of Munich
Conditions:
Prediction of Volume Responsiveness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
* test for volume responsiveness * PiCCO-guided infusion over a pre-defined period of time
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01227304
Start Date
July 1 2010
End Date
December 1 2010
Last Update
October 25 2010
Active Locations (1)
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1
2nd Medical Department, Klinikum rechts der Isar
Munich, Germany, 81675