- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02771002
Assessment of Peripheral Perfusion in the Critically Ill Patient (CRTPPI)
June 21, 2017 updated by: University Hospital Inselspital, Berne
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bern, Switzerland, 3010
- Bern University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Female and male septic shock patients with ICU admission Female and male patients after cardiac surgery with ICU admission healthy volunteers
Description
Septic patient:
Inclusion criteria:
- 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)
Exclusion criteria:
- 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
Patient after cardiac surgery:
Inclusion criteria:
- ICU admission after coronary artery bypass grafting or valve surgery with cardiopulmonary bypass
- General consent with admission at the University hospital
Exclusion criteria:
- 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:
Inclusion criteria:
- Informed consent as documented by signature (Appendix Informed Consent Form)
Exclusion criteria:
- Age <18 or >80 years
- known peripheral artery disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Peripheral Perfusion index measured with pulse-oximetry 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
|
Peripheral Perfusion index measured with pulse-oximetry 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
|
Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
CRT in healthy controls, septic shock patients and patients rewarming after cardiac surgery
|
measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sonographic assesment of solid organ perfusion
Time Frame: within 24h after ICU admission and 24h after first measurement
|
solid organ perfusion measured by ultrasound
|
within 24h after ICU admission and 24h after first measurement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2016
Primary Completion (Actual)
March 28, 2017
Study Completion (Actual)
March 28, 2017
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 12, 2016
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 21, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CRTPPI 04/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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