Assessment of Peripheral Perfusion in the Critically Ill Patient

NCT ID: NCT02771002

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-13
• Study Completion Date: 2017-03-28

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.

Conditions

Peripheral Perfusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Peripheral Perfusion index by Carescape Patientenmonitor

Intervention Type: DEVICE

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

Peripheral Perfusion index by Carescape Patientenmonitor

Intervention Type: DEVICE

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

Peripheral Perfusion index by Carescape Patientenmonitor

Intervention Type: DEVICE

Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor

Interventions

Peripheral Perfusion index by Carescape Patientenmonitor

Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor

Intervention Type: DEVICE

Eligibility Criteria

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)

• ICU admission after coronary artery bypass grafting or valve surgery with cardiopulmonary bypass
• General consent with admission at the University hospital

• Informed consent as documented by signature (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:

• 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:

• Age <18 or >80 years
• known peripheral artery disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

CRTPPI 04/16

Identifier Type: -

Identifier Source: org_study_id