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Assessment of Peripheral Perfusion in the Critically Ill Patient

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02771002
Acronym
CRTPPI
Enrollment
100
Registered
2016-05-12
Start date
2016-07-13
Completion date
2017-03-28
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Perfusion

Keywords

critically ill patients, septic shock, peripheral perfusion index, capillary refill time, mottling score, microcirculation

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.

Interventions

DEVICEPeripheral Perfusion index by Carescape Patientenmonitor

Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
peripheral perfusion indexmeasurement 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

MeasureTime frameDescription
capillary refill timemeasurement 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

MeasureTime frameDescription
sonographic assesment of solid organ perfusionwithin 24h after ICU admission and 24h after first measurementsolid organ perfusion measured by ultrasound

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026