Skip to main content
OpenTrials
Completed

NCT Number: NCT02771002

Assessment of Peripheral Perfusion in the Critically Ill Patient

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral Perfusion index by Carescape Patientenmonitor

Device

Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor

Primary outcomes

  1. peripheral perfusion index

    Time frame: 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 outcomes

  1. capillary refill time

    Time frame: 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 outcomes

  1. sonographic assesment of solid organ perfusion

    Time frame: within 24h after ICU admission and 24h after first measurement

    solid organ perfusion measured by ultrasound

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: CRTPPI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2016
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.