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

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

Study Overview

• Status: Unknown
• Conditions: Prediction of Volume Responsiveness
• Intervention / Treatment: Device: PiCCO-parameter-guided volume challenge

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81675
    • Recruiting
    • 2nd Medical Department, Klinikum rechts der Isar
    • Contact: Wolfgang Huber, MD; Phone Number: +49-89-4140-2214; Email: wolfgang.huber@lrz.tum.de
    • Principal Investigator: Wolfgang Huber, MD
    • Sub-Investigator: Josef Hoellthaler, MD
    • Sub-Investigator: Andrea Herrmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 15 minutes	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	30 minutes after start of infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technical University of Munich

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: October 21, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: SMOOCH-1