Pulse Photoplethysmography as an Early Tool for the Diagnosis of Sepsis

NCT04149132 | Completed

• 1 other identifier: PROUD-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

Early management of sepsis is associated with better outcome. However, this requires early recognition of the sepsis host. One recently developed customized pulse photoplethysmography (PPG) device manages to measure nitric oxide (NO) that is released from vascular endothelium and seems promising for earlier sepsis diagnosis than conventional approaches. Aim of the project To evaluate the diagnostic performance of the PPG device for the early diagnosis of sepsis is to evaluate the diagnostic performance of the PPG device for the early diagnosis of sepsis

Conditions

Sepsis

Keywords

early diagnosis; infection; pulse photoplethysmography

Outcome Measures

Primary Outcomes (1)

• Sensitivity of PPG for the diagnosis of sepsis.

  Sensitivity of PPG for the diagnosis of sepsis.

  72 hours

Secondary Outcomes (7)

• Correlation of PPG (absolute number) with qSOFA score (absolute number)

  72 hours

• Correlation of PPG (absolute number) with SOFA score (absolute number)

  72 hours

• Correlation of time (in minutes) of sepsis diagnosis between PPG (absolute number) and SOFA score (absolute number)

  72 hours

• Correlation of time (in minutes) of sepsis diagnosis between PPG (absolute number) and hypotension (mmHg)

  72 hours

• The specificity, positive predictive value (PPV) and negative predictive value (NPV) of PPG for the diagnosis of sepsis

  72 hours

Study Arms (1)

Patients without sepsis

Patients admitted and hospitalized for infections without sepsis and for other reasons in departments of Internal Medicine and Intensive Care Units

Device: pulse photoplethysmography (PPG); Diagnostic Test: Measurements of nitric oxide (NO) and malondialdehyde (MDA)

Interventions

pulse photoplethysmography (PPG) DEVICE

PPG and systolic blood pressure recording will be performed every two hours for three consecutive days. PPG reading will last two minutes and peaks of NO productions will be captured. Day 1 is considered the day of signing the informed consent followed by the first recording. On the first PPG recording of the same days i.e. on days 1, 2 and 3 the investigators will collect blood from the patients

Patients without sepsis

Measurements of nitric oxide (NO) and malondialdehyde (MDA) DIAGNOSTIC_TEST

On the first PPG recording of the same days i.e. on days 1, 2 and 3 the investigators will collect blood from the patients. NO will be measured in serum samples by the Griess reaction. MDA that is considered an index of oxidant status will be measured in serum samples by the thiobarbiturate assay and analysis by high-performance liquid chromatography (HPLC)

Patients without sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Screening will be done for the inclusion and exclusion criteria in all patients admitted or hospitalized in the participating sites. Participants will be patients meeting all inclusion criteria and none of the exclusion criteria

You may qualify if:

• Age equal to or greater than 18 years
• Both genders
• Written informed consent provided by the patients or by first-degree relatives in case of patients unable to consent.
• Any of two:
• Any infection in a patient with total SOFA score equal to 0 or 1 Patient without sepsis prone to the development of sepsis defined as patients with Charlson's Comorbidity Index (CCI) more than 2 irrespective the reason of admission. These patients are considered prone to infection based on previous findings of our group showing that CCI more than 2 is an independent predisposing factor for sepsis

You may not qualify if:

• Age below 18 years
• Denial to consent
• Any stage 4 malignancy
• Any do not resuscitate decision
• Active tuberculosis (TB) as defined by the co-administration of drugs for the treatment of TB
• Pregnancy or lactation

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (4)

Intensive Care Unit, "Korgialenio - Benakio" General Hospital of Athens

Athens, 11526, Greece

Location

Department of Clinical Therapeutics, "Alexandra" General Hospital of Athens, National and Kapodistrian University of Athens, Medical School

Athens, 11528, Greece

Location

2nd Department of Critical Care, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School

Athens, 12462, Greece

Location

4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School

Athens, 12462, Greece

Location

MeSH Terms

Conditions

Sepsis; Disease; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonios Papadopoulos, MD, PhD

  4th Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: October 30, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

GR (4)