Rapid Test for Detection of the Focus of Infection in Post Neurosurgical Patients.

NCT03252028 | Unknown

• 1 other identifier: LINPEAS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Due to anatomical restrictions, the inflammatory response to intra-cerebral bacterial infections exposes swollen brain tissues to pressure and ischemia, resulting in life-threatening damage. However, diagnosing meningitis in patients after neurosurgery is complicated, due to brain tissue damage and changes in cerebrospinal fluid (CSF) caused by surgery. Hepatocyte growth factor (HGF) is a local, acute-phase protein. Previous studies on community-acquired septic meningitis reported high levels of intrathecal-produced HGF. Aim: The aim of present study is to evaluate a new platform for qualitative determination of HGF in body fluids and revealing the site of injury. Method: Based on a reverse-methachromacy method, strips are prepared. The surface on the strip changes colour to blue upon contact with HGF. Plan: CSF, urine and sputum of patients that develop fever post neurosurgery are analysed with the test and the results compared with conventional diagnostic methods. Clinical value: A rapid, equipment-free test gives the opportunity to identify the infectious focus in the infected organ long before culture results are available.

Conditions

Infection, Bacterial; Antibiotic Resistant Infection; Diagnostic Self Evaluation; Meningitis, Bacterial; Nosocomial Infection

Keywords

Hepatocyte growth factor, Nosocomial infections, VAP, Meningitis, In vitro, point of care, rapid test

Outcome Measures

Primary Outcomes (1)

• detection of infections in intensive care unit

  analyse of different body fluids to detect the focus of infections post neurosurgical fever

  4 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all post-neurosurgical patients in neuro intensive care unit university hospital Linkoping, Sweden

You may qualify if:

• all post neurosurgical patients with suspect infection or fever

Sponsors & Collaborators

• Fariba Nayeri: lead

Study Sites (2)

Neurosurgery dept. University Hospital

Linköping, Östergötland County, 581 85, Sweden

RECRUITING

Neurosurgery department, University Hospital

Linköping, Östergötland County, 58185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples from CSF, Sputum, Urine, Blood

MeSH Terms

Conditions

Bacterial Infections; Meningitis, Bacterial; Cross Infection; Deafness, Autosomal Recessive 39; Meningitis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fariba Nayeri, MD

CONTACT

+46702080804; fariba.nayeri@regionostergotland.se

Annette Theodorsson, Professor

CONTACT

+46734607538; annette.theodorsson@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, associated professor

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 17, 2017
• Study Start: December 2, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

SE (2)