Assessment of Peripheral Perfusion in the Critically Ill Patient (CRTPPI)

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: Peripheral Perfusion
• Intervention / Treatment: Device: Peripheral Perfusion index by Carescape Patientenmonitor

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

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

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	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

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sonographic assesment of solid organ perfusion	solid organ perfusion measured by ultrasound	within 24h after ICU admission and 24h after first measurement

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne

Study record dates

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: septic shock; microcirculation; critically ill patients; peripheral perfusion index; capillary refill time; mottling score
• Other Study ID Numbers: CRTPPI 04/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No