SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
NCT ID: NCT01227304
Last Updated: 2010-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2010-07-31
2010-12-31
Brief Summary
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* PiCCO-guided infusion over a pre-defined period of time
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Test of volume responsiveness using crystalloids
PiCCO-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.
Interventions
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PiCCO-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pulmonary edema: extravascular lungwater index \> 20ml/kg
* Cardiogenic shock without volume deficiency (cardiac index \<2L/min; global enddiastolic volume index \> 850ml/sqm)
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Klinikumr rechts der Isar
Locations
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2nd Medical Department, Klinikum rechts der Isar
Munich, , Germany
Countries
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Facility Contacts
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Other Identifiers
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SMOOCH-1
Identifier Type: -
Identifier Source: org_study_id