Peripheral PerfusionCRTPPINCT02771002
Assessment of Peripheral Perfusion in the Critically Ill Patient
An observational study of Peripheral Perfusion, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral perfusion in patients in septic shock and after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Perfusion
- What is being tested?
- Peripheral Perfusion index by Carescape Patientenmonitor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jul 2016to 28 Mar 2017
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female and male septic shock patients with ICU admission Female and male patients after cardiac surgery with ICU admission healthy volunteers
Who may be able to join
- ICU admission with septic shock defined as:
- documented infection (suspected or confirmed) AND
- systemic mean blood pressure <65mmHg requiring any dose of vasopressor despite adequate fluid resuscitation (min. 20ml/kg crystalloids) AND
- lactate >2mmol/l
- Deferred consent by a relative with following informed consent by patient as documented by signatures (Appendix Informed Consent Form)
- ICU admission after coronary artery bypass grafting or valve surgery with cardiopulmonary bypass
- General consent with admission at the University hospital
- Informed consent as documented by signature (Appendix Informed Consent Form)
Who cannot join
- Age <18 or >80 years
- present or suspected myocardial ischemia
- acute pulmonary embolism
- known liver disease - Child-Pugh -Class B or C
- known chronic renal failure
- known peripheral artery disease
Show all 17Show fewer
- Patient after cardiac surgery:
- Age <18 or >80 years
- known peripheral artery disease
- no or only low dose of vasopressors (<300µg/h) at ICU admission
- present or suspected myocardial ischemia
- acute pulmonary embolism
- known liver disease - Child-Pugh -Class B or C
- known chronic renal failure
- Healthy volunteers:
- Age <18 or >80 years
- known peripheral artery disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Assessment of Peripheral Perfusion by Capillary Refill Time and Peripheral Perfusion Index
The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral perfusion in patients in septic shock and after cardiac surgery.
Read the detailed description
The aim of this study is to validate PPI as a continuous, objective measurement of peripheral perfusion indicated by clinical sings of tissue perfusion in patients with septic shock. Furthermore, PPI shall be compared to the perfusion of solid organs evaluated by ultrasound of liver, kidney and gut. In a group of healthy volunteers the investigators will determine normal values in ambient temperature and after cooling of an extremity. Another group of patients after cardiac surgery, where usually a poor tissue perfusion without metabolic failure is present will serve as another "control" population in their post-surgery stabilization period. The values from healthy volunteers and cardiac surgery patients will be compared to those of patients in septic shock.
- Conditions
- Peripheral Perfusion
- Being tested
- Peripheral Perfusion index by Carescape Patientenmonitor
- Keywords
- critically ill patients, septic shock, peripheral perfusion index, capillary refill time, mottling score, microcirculation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Perfusion index by Carescape PatientenmonitorDevice
Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients | measurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until normalisation of lactate sonographic assesment of perfusion of solid organs once within 24h after admission Receives: Device: Peripheral Perfusion index by Carescape Patientenmonitor | |
| patients rewarming after cardiac surgery | measurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until extubation Receives: Device: Peripheral Perfusion index by Carescape Patientenmonitor | |
| healthy volunteers | measurements of peripheral perfusion including capillary refill time and peripheral perfusion index in ambient temperature and after cooling of extremity Receives: Device: Peripheral Perfusion index by Carescape Patientenmonitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral perfusion index
PPI in healthy controls, septic shock patients and patients rewarming after cardiac surgery
Measured: measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)
Secondary outcomes (1)
capillary refill time
CRT in healthy controls, septic shock patients and patients rewarming after cardiac surgery
Measured: measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start13 Jul 2016
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral PerfusionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771002
- Sponsor's protocol ID
- CRTPPI 04/16
- Acronym
- CRTPPI
- Status last verified
- Jun 2017
- First submitted
- 2 May 2016
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Assessment of Peripheral Perfusion by Capillary Refill Time and Peripheral Perfusion Index
- ClinicalTrials.gov ID
- NCT02771002
- Acronym / sponsor ID
- CRTPPI / CRTPPI 04/16
- Conditions
- Peripheral Perfusion
- Keywords
- critically ill patients, septic shock, peripheral perfusion index, capillary refill time, mottling score, microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 12 May 2016 (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.
The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral perfusion in patients in septic shock and after cardiac surgery.
Detailed description
The aim of this study is to validate PPI as a continuous, objective measurement of peripheral perfusion indicated by clinical sings of tissue perfusion in patients with septic shock. Furthermore, PPI shall be compared to the perfusion of solid organs evaluated by ultrasound of liver, kidney and gut. In a group of healthy volunteers the investigators will determine normal values in ambient temperature and after cooling of an extremity. Another group of patients after cardiac surgery, where usually a poor tissue perfusion without metabolic failure is present will serve as another "control" population in their post-surgery stabilization period. The values from healthy volunteers and cardiac surgery patients will be compared to those of patients in septic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| septic shock patients | – | Device: Peripheral Perfusion index by Carescape Patientenmonitormeasurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until normalisation of lactate sonographic assesment of perfusion of solid organs once within 24h after admission |
| patients rewarming after cardiac surgery | – | Device: Peripheral Perfusion index by Carescape Patientenmonitormeasurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until extubation |
| healthy volunteers | – | Device: Peripheral Perfusion index by Carescape Patientenmonitormeasurements of peripheral perfusion including capillary refill time and peripheral perfusion index in ambient temperature and after cooling of extremity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male septic shock patients with ICU admission Female and male patients after cardiac surgery with ICU admission healthy volunteers
Key inclusion criteria (8 listed)
- ICU admission with septic shock defined as:
- documented infection (suspected or confirmed) AND
- systemic mean blood pressure <65mmHg requiring any dose of vasopressor despite adequate fluid resuscitation (min. 20ml/kg crystalloids) AND
- lactate >2mmol/l
- Deferred consent by a relative with following informed consent by patient as documented by signatures (Appendix Informed Consent Form)
Key exclusion criteria (17 listed)
- Age <18 or >80 years
- present or suspected myocardial ischemia
- acute pulmonary embolism
- known liver disease - Child-Pugh -Class B or C
- known chronic renal failure
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 |
|---|---|---|
| Peripheral Perfusion index by Carescape PatientenmonitorPeripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor | Device | healthy volunteers, patients rewarming after cardiac surgery, septic shock patients |
Primary outcome
peripheral perfusion index
Time frame: measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)
PPI in healthy controls, septic shock patients and patients rewarming after cardiac surgery
1 secondary outcome
capillary refill time
Time frame: measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Peripheral Perfusion
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Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
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Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
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Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Perfusion, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 17 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: finished, as of the sponsor's last update on 22 Jun 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral perfusion index (time frame: measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)). 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 22 Jun 2017.