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Lactoferrin Use in ICU Patients

ConditionCritical Illness
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMansoura University Hospital

About this trial

Introduction:

Lactoferrin has several uses due to its effects. It has anti-inflammatory, antioxidant, immunomodulatory, antibacterial, antifungal, and antiviral effects. Its safety is proven by food and drug administration.

Aims:

The objective is to study the effect of lactoferrin on improving clinical outcomes in ICU patients, and also to evaluate its safety.

Patients and populations:

A sample of 660 patients (330 patients in both groups A, and B) who will be admitted to ICU departments in Mansoura university hospital will be used to represent the population in ICU.

Methods:

A sample of 660 participants was randomized 1:1 into two groups (group A (330 patients), and group B (330 patients)).

This study is a single blind, randomized controlled clinical trial. Randomization was performed by independent clinical pharmacists working in hospital ICU departments.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The inclusion criteria for patients to participate in this research include adult (age ≥ 18 years) patients admitted to ICU for any reason or disease.

Disqualifiers

inability to give informed consent by patients or their relative,

history of hypersensitivity to milk products,

history of lactoferrin use in the past 6 months,

patients with lactose intolerance,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactoferrin

    Drug

    antioxidant, immunomodulatory, anti-inflammatory, antimicrobial effect

  • Antioxidant therapies

    Drug

    Acetyl cysteine 600 mg / 12 hr

  • Dexamethasone

    Drug

    dexamethasone I.V 8 mg / day

  • Antibacterial therapies

    Drug

    Antibacterial drugs in their approved doses

Treatment groups

660 Participants
are divided into 2 treatment groups
Group A: LactoferrinExperimental treatment 1 intervention
Group B: StandardActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

28-days mortality rate

Dead or alive

Time frame
28 days
2

Number of Participants With any allergic or hypersensitivity reactions

incidence of any allergic or hypersensitivity reactions

Time frame
up to 60 days

Secondary outcomes

1

Day of death

Death day

Time frame
up to 60 days
2

Incidence of need for Invasive Mechanical Ventilation

yes or no

Time frame
up to 60 days
3

Oxygen Support Duration

Duration of need for Oxygen Support

Time frame
up to 60 days
4

Duration of ICU stay

ICU stay duration

Time frame
up to 60 days

Other outcomes

1

Glasgow Coma Score (GCS) on day 3

minimum 0 to maximum 15, higher scores mean better outcomes

Time frame
day 3
2

Glasgow Coma Score (GCS) on day 7

minimum 0 to maximum 15, higher scores mean better outcomes

Time frame
day 7
3

Glasgow Coma Score (GCS) on day 14

minimum 0 to maximum 15, higher scores mean better outcomes

Time frame
day 14
4

Glasgow Coma Score (GCS) on day 28

minimum 0 to maximum 15, higher scores mean better outcomes

Time frame
day 28

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University Hospital

Lead sponsor

King Salman International university

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: