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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by Technische Universität München.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Technische Universität München

ClinicalTrials.gov Identifier:

NCT01227304

First received: October 21, 2010

Last updated: October 22, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 21, 2010
Last Updated Date	October 22, 2010
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 22, 2010)	Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 15 minutes [ Time Frame: 15 minutes after start of infusion ] [ Designated as safety issue: Yes ] Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 30 minutes [ Time Frame: 30 minutes after start of infusion ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01227304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 22, 2010)	Predictive capabilities of Cardiac Index (measured by pulse contour) [ Time Frame: within 30 minutes after start of infusion ] [ Designated as safety issue: Yes ] Comparison of global enddiastolic volume index to baseline values [ Time Frame: 30 minutes after start of infusion ] [ Designated as safety issue: Yes ] Comparison of central venous pressure levels to baseline values [ Time Frame: 30 minutes after start of infusion ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
Official Title ^ICMJE	Not Provided
Brief Summary	test for volume responsiveness PiCCO-guided infusion over a pre-defined period of time
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Prediction of Volume Responsiveness
Intervention ^ICMJE	Device: 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.
Study Arm (s)	Experimental: Test of volume responsiveness using crystalloids Intervention: Device: PiCCO-parameter-guided volume challenge
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01227304
Other Study ID Numbers ^ICMJE	SMOOCH-1
Has Data Monitoring Committee	Not Provided
Responsible Party	Wolfgang Huber, Klinikumr rechts der Isar
Study Sponsor ^ICMJE	Technische Universität München
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Technische Universität München
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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