Clinical trial NCT04249050: Effects of Immunonutrition in Patients With Pneumonia
Official title: Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Lung Infection
Muscle Loss
Malnutrition
Pulmonary Disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project is a randomized controlled trial taking place in the North Zealand hospital in the city Hilleroed, Denmark.

The aim is to investigate the potential beneficial effects of immunonutrition containing fish oil, arginine and RNA, on the acute immune response in patients with pneumonia.

Detailed description: Immunonutrition has a well-documented beneficial effect on surgical patients by strengthening the immune system and reducing the following: inflammation, the number of infections as well as hospitalization time. A study in operated patients demonstrated the benefit of immunonutrition by reducing unwanted inflammation, measured by the pro-inflammatory signalling protein, interleukin-6. The same study saw a smaller decrease in immune function (measured as the level of phagocytosis) in the group receiving immunonutrition than in the control group. This project will investigate whether similar effects can be detected in patients with pneumonia.

The project is being carried out in a collaboration between the University of Copenhagen, The main hospital of Copenhagen (Rigshospitalet) and North Zealand Hospital. The project is a randomized clinical intervention study, which spans 10 days. Participants are allocated to the intervention group or the control group. The project is being carried out at the North Zealand hospital, at the Department of Pulmonary- and Infectious Diseases.

The intervention group receives the department's standard treatment (Standard Of Care) + immunonutrition, while the control group receives the hospital department's standard treatment (Standard Of Care). On a daily basis, the patient's clinical condition and the activity of the immune system is measured for the purpose of determine whether there is an effect of immunonutrition.

Eligibility criteria: Inclusion Criteria:

* Authorized individuals diagnosed with pneumonia who speak and write in danish

Exclusion Criteria:

* individuals with Immunodeficiency
* individuals with another primary diagnose
* individuals with an allergy against product ingredients
* individuals with dementia
* individuals with dysphagia
* individuals with cancer in treatment
* individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment

Primary outcomes:
measure: Interleukin-6
timeFrame: daily measure from first day of inclusion until discharge (maximum 10 days)
Secondary outcomes:
measure: Length of stay
timeFrame: From admittance to discharge (maximum 10 days)
measure: Hand grip strength
timeFrame: Daily from admittance to discharge (maximum 10 days)
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Department of Lung Medicine and Infectious Diseases
Study officials:
affiliation: North Zealand Hospital, Hilleroed, Denmark
name: Birgitte L Madsen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
citation: Marimuthu K, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of the effect of combinations of immune modulating nutrients on outcome in patients undergoing major open gastrointestinal surgery. Ann Surg. 2012 Jun;255(6):1060-8. doi: 10.1097/SLA.0b013e318252edf8.