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

Not Applicable

• Conditions: Prediction of Volume Responsiveness
• Interventions: Device: PiCCO-parameter-guided volume challenge

• Registration Number: NCT01227304
• Lead Sponsor: Technical University of Munich

Brief Summary

* test for volume responsiveness

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-10
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-22
• Last Update Submitted: 2010-10-22
• Study First Posted: 2010-10-25
• Last Update Posted: 2010-10-25
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test of volume responsiveness using crystalloids	PiCCO-parameter-guided volume challenge	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

2nd Medical Department, Klinikum rechts der Isar; 🇩🇪 Munich, Germany