Fungal Infection in Patients in Intensive Care Units

NCT ID: NCT04684342

Last Updated: 2020-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-03-31

Brief Summary

Predictors of fungal infection in non-neutropenic patients in intensive care units and the aim of the study is To evaluate the frequency of fungal infection in non-neutropenic patients in Intensive Care Units.

To evaluate the risk factors of fungal infection in these patients.

Detailed Description

The incidence of candidemia in the overall population ranges from 1.7 to 10 episodes per 100,000 inhabitants and Candida is one of the ten leading causes of bloodstream infections in developed countries. An estimated 33-55% of all episodes of candidemia occur in intensive care units (ICU) and are associated with mortality rates ranging from 5% to 71%. Candida fungemia may have an endogenous or an exogenous origin, and in recent years a growing proportion of episodes of candidemia have been caused by Candida species other than albicans. The most important independent conditions predisposing to candidemia in ICU patients include prior abdominal surgery, intravascular catheters, acute renal failure, parenteral nutrition, broad-spectrum antibiotics, a prolonged ICU stay, the use of corticosteroids and mucosal colonization with Candida. In recent years, several studies have shown that ICU patients with mucosal Candida colonization, particularly if multifocal, are at a higher risk for invasive candidiasis, and that colonization selects a population amenable to antifungal prophylaxis or empirical therapy. Candidemia in ICUs is associated with a con- siderable increase in hospital costs and length of hospital stay.

Invasive fungal infection (IFI) is a grave infection associated with serious effects in patients with chronic diseases including liver cirrhosis. The diagnosis of IFI re- quires histopathological evidence of tissue invasion, or isolation in blood cultures, or isolation from a normally sterile body fluid or site, with samples collected intra-op- eratively or by percutaneous needle aspiration. Awareness of IFI has been increased in clinical practice with the increased survival of patients in immunocompromised states. Such infections are associated with a high morbidity and significant mortality, requiring early diagnosis and appropriate treatment, but also optimal prophylaxis in patients at high risk.

Globally, several studies had assessed fungal infections in non-neutropenic patients, however, to our knowledge, searching for fungal infections in these patients are un- derestimated in our locality.

Conditions

Fungal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

cirrhotic ICU Patients

about 150 patients with cirrhosis fulfill- ing the inclusion criteria that will be admitted to Tropical Medicine and Gas- troenterology Department, Al-Rajhi Liver Hospital, Assiut University Hospi- tals) will be evaluated for fungal infection.

Group Type: EXPERIMENTAL

Routine Laboratory investigations

Intervention Type: DIAGNOSTIC_TEST

1. Complete blood picture

2. Liver function test and prothrombine time & concentration.

3. Blood urea and creatinine

4. Blood glucose, serum Na and K

5. CRP and ESR

6. Clinical specimens will be collected from patients according to the suspected site of infection (e.g. blood, urine, ascitic fluid, sputum or endo- tracheal aspirates) VITEK 2Compact inflammatory markers

Interventions

Routine Laboratory investigations

1. Complete blood picture

2. Liver function test and prothrombine time & concentration.

3. Blood urea and creatinine

4. Blood glucose, serum Na and K

5. CRP and ESR

6. Clinical specimens will be collected from patients according to the suspected site of infection (e.g. blood, urine, ascitic fluid, sputum or endo- tracheal aspirates) VITEK 2Compact inflammatory markers

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adult Patients with liver cirrhosis that will be clinically suspected to have in- fection.

Exclusion Criteria

• Age < 18 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdou Mahmoud

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Zakaria, Professor

Role: STUDY_CHAIR

Assiut University

Central Contacts

Mahmoud A. Abdelmoula

Role: CONTACT

Phone: 01113983636

Email: abdou.mahmoud93@gmail.com

References

Leon DA, McCambridge J. Liver cirrhosis mortality rates in Britain from 1950 to 2002: an analysis of routine data. Lancet. 2006 Jan 7;367(9504):52-6. doi: 10.1016/S0140-6736(06)67924-5.

Reference Type: BACKGROUND

PMID: 16399153 (View on PubMed)

Runyon BA; AASLD. Introduction to the revised American Association for the Study of Liver Diseases Practice Guideline management of adult patients with ascites due to cirrhosis 2012. Hepatology. 2013 Apr;57(4):1651-3. doi: 10.1002/hep.26359. No abstract available.

Reference Type: BACKGROUND

PMID: 23463403 (View on PubMed)

Bucsics T, Schwabl P, Mandorfer M, Peck-Radosavljevic M. Prognosis of cirrhotic patients with fungiascites and spontaneous fungal peritonitis (SFP). J Hepatol. 2016 Jun;64(6):1452-4. doi: 10.1016/j.jhep.2016.01.039. Epub 2016 Feb 23. No abstract available.

Reference Type: BACKGROUND

PMID: 26916528 (View on PubMed)

Other Identifiers

Fungal infection in ICU

Identifier Type: -

Identifier Source: org_study_id