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

Prediction of Volume Responsiveness Clinical Trial

— SMOOCH  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01227304
• Other study ID #: SMOOCH-1
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2010
• Last updated: October 22, 2010
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2010
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee of the Technical University of Munich
• Study type: Interventional

Clinical Trial Summary

• test for volume responsiveness

• PiCCO-guided infusion over a pre-defined period of time

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prediction of Volume Responsiveness

Intervention

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.

Locations

Country	Name	City	State
Germany	2nd Medical Department, Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Predictive capabilities of Cardiac Index (measured by pulse contour)		within 30 minutes after start of infusion	Yes
Secondary	Comparison of global enddiastolic volume index to baseline values		30 minutes after start of infusion	Yes
Secondary	Comparison of central venous pressure levels to baseline values		30 minutes after start of infusion	Yes