Assessment of Peripheral Perfusion in the Critically Ill Patient

NCT02771002 | Completed

• 1 other identifier: CRTPPI 04/16
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Perfusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• capillary refill time

  measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)

Other Outcomes (1)

• sonographic assesment of solid organ perfusion

  within 24h after ICU admission and 24h after first measurement

Study Arms (3)

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

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

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

Interventions

Peripheral Perfusion index by Carescape Patientenmonitor DEVICE

Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor

healthy volunteers; patients rewarming after cardiac surgery; septic shock patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: NONE RETAINED

blood samples for detecting lactate

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 12, 2016
• Study Start: July 13, 2016
• Primary Completion: March 28, 2017
• Study Completion: March 28, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)