Assessment of Peripheral Perfusion in the Critically Ill Patient

Study Overview
=================
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.

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.

Official Title
-----------------
Evaluation of the Clinical Assessment of Peripheral Perfusion by Capillary Refill Time and Peripheral Perfusion Index

Conditions
-----------------
Peripheral Perfusion

Intervention / Treatment
-----------------
* Device: Peripheral Perfusion index by Carescape Patientenmonitor


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| septic shock patients<br>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<br>* Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor<br>|
| patients rewarming after cardiac surgery<br>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<br>* Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor<br>|
| healthy volunteers<br>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<br>* Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral perfusion index | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critically ill patients, septic shock, peripheral perfusion index, capillary refill time, mottling score, microcirculation