Assessment of Peripheral Perfusion in the Critically Ill Patient

Peripheral Perfusion Clinical Trial

— CRTPPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771002
• Other study ID #: CRTPPI 04/16
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: June 21, 2017
• Start date: July 13, 2016
• Est. completion date: March 28, 2017

Study information

• Verified date: June 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Perfusion

Intervention

Device:
• Peripheral Perfusion index by Carescape Patientenmonitor
Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor

Locations

Country	Name	City	State
Switzerland	Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sonographic assesment of solid organ perfusion	solid organ perfusion measured by ultrasound	within 24h after ICU admission and 24h after first measurement
Primary	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	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)