CRTPPI: Assessment of Peripheral Perfusion in the Critically Ill Patient
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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 |
Device: Peripheral Perfusion index by Carescape Patientenmonitor
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 |
Device: Peripheral Perfusion index by Carescape Patientenmonitor
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 |
Device: Peripheral Perfusion index by Carescape Patientenmonitor
Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor
|
Outcome Measures
Primary Outcome Measures
- peripheral perfusion index [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
Secondary Outcome Measures
- capillary refill time [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
Other Outcome Measures
- sonographic assesment of solid organ perfusion [within 24h after ICU admission and 24h after first measurement]
solid organ perfusion measured by ultrasound
Eligibility Criteria
Criteria
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
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Deferred consent by a relative with following informed consent by patient as documented by signatures (Appendix Informed Consent Form)
Exclusion criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bern University Hospital | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRTPPI 04/16