Prediction of Volume ResponsivenessSMOOCHNCT01227304
SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
A study testing PiCCO-parameter-guided volume challenge in people with Prediction of Volume Responsiveness, run by Technical University of Munich at 1 site in Germany.
Trial summary
test for volume responsiveness PiCCO-guided infusion over a pre-defined period of time Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediction of Volume Responsiveness
- What is being tested?
- PiCCO-parameter-guided volume challenge
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Femoral access of the central venous catheter precluding application of the normal ranges of global enddiastolic volume index and central venous pressure.
- Absence of sinus rhythm and/or controlled ventilation precluding the use of stroke volume variation.
- Evidence of increased intraabdominal pressure which is known to further reduce the usefulness of central venous pressure.
- Contradictory suggestions by stroke volume variation and global enddiastolic volume index.
- Intolerance of passive leg raising.
- Absence of therapeutic alternatives to volume resuscitation.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
2nd Medical Department, Klinikum rechts der Isar
Munich, 81675
Wolfgang Huber, MD, +49-89-4140-2214, wolfgang.huber@lrz.tum.de
Wolfgang Huber, MD
About this study
- test for volume responsiveness
- PiCCO-guided infusion over a pre-defined period of time
- Conditions
- Prediction of Volume Responsiveness
- Being tested
- PiCCO-parameter-guided volume challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO-parameter-guided volume challengeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Test of volume responsiveness using crystalloids | Experimental | Not described Receives: Device: PiCCO-parameter-guided volume challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 15 minutes
Measured: 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
Measured: 30 minutes after start of infusion
Secondary outcomes (3)
Predictive capabilities of Cardiac Index (measured by pulse contour)
Measured: within 30 minutes after start of infusion
Comparison of global enddiastolic volume index to baseline values
Measured: 30 minutes after start of infusion
Comparison of central venous pressure levels to baseline values
Measured: 30 minutes after start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediction of Volume ResponsivenessStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227304
- Sponsor's protocol ID
- SMOOCH-1
- Acronym
- SMOOCH
- Status last verified
- Oct 2010
- First submitted
- 21 Oct 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT01227304
- Acronym / sponsor ID
- SMOOCH / SMOOCH-1
- Conditions
- Prediction of Volume Responsiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- test for volume responsiveness
- PiCCO-guided infusion over a pre-defined period of time
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test of volume responsiveness using crystalloids | Experimental | Device: PiCCO-parameter-guided volume challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCCO-parameter-guided volume challengeInfusion 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. | Device | Test of volume responsiveness using crystalloids |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
Related trials for Prediction of Volume Responsiveness
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
Recruiting
Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) - "HemodynamECMOnitoring-VV Study"
ECMO Treatment, ARDS
Recruiting
Hemodynamic Monitoring and Fluid Responsiveness in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) - "HemodynamECMOnitoring-VA Study"
ECMO Treatment, ARDS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2nd Medical Department, Klinikum rechts der Isar
Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PiCCO-parameter-guided volume challenge in people with Prediction of Volume Responsiveness, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2010.