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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Technische Universität München.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227304
First Posted: October 25, 2010
Last Update Posted: October 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  Purpose
  • test for volume responsiveness
  • PiCCO-guided infusion over a pre-defined period of time

Condition Intervention
Prediction of Volume Responsiveness Device: PiCCO-parameter-guided volume challenge

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by Technische Universität München:

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

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)
  Contacts and Locations
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
  More Information

Responsible Party: Wolfgang Huber, Klinikumr rechts der Isar
ClinicalTrials.gov Identifier: NCT01227304     History of Changes
Other Study ID Numbers: SMOOCH-1
First Submitted: October 21, 2010
First Posted: October 25, 2010
Last Update Posted: October 25, 2010
Last Verified: October 2010