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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wolfgang Huber, Klinikumr rechts der Isar
ClinicalTrials.gov Identifier: NCT01227304     History of Changes
Other Study ID Numbers: SMOOCH-1
Study First Received: October 21, 2010
Last Updated: October 22, 2010
Health Authority: Germany: Ethics Committee of the Technical University of Munich

ClinicalTrials.gov processed this record on July 29, 2014