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

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ClinicalTrials.gov Identifier: NCT01227304
Recruitment Status : Unknown
Verified October 2010 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Sponsor:
Information provided by:
Technische Universität München

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

Condition or disease Intervention/treatment
Prediction of Volume Responsiveness Device: PiCCO-parameter-guided volume challenge

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Test of volume responsiveness using crystalloids 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.



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Predictive capabilities of Cardiac Index (measured by pulse contour) [ Time Frame: within 30 minutes after start of infusion ]
  2. Comparison of global enddiastolic volume index to baseline values [ Time Frame: 30 minutes after start of infusion ]
  3. Comparison of central venous pressure levels to baseline values [ Time Frame: 30 minutes after start of infusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227304


Locations
Germany
2nd Medical Department, Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Wolfgang Huber, MD    +49-89-4140-2214    wolfgang.huber@lrz.tum.de   
Principal Investigator: Wolfgang Huber, MD         
Sub-Investigator: Josef Hoellthaler, MD         
Sub-Investigator: Andrea Herrmann         
Sponsors and Collaborators
Technische Universität München

Responsible Party: Wolfgang Huber, Klinikumr rechts der Isar
ClinicalTrials.gov Identifier: NCT01227304     History of Changes
Other Study ID Numbers: SMOOCH-1
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010