The Effect of Lactoferrin in Improving Clinical Outcomes in ICU Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- 28-days mortality rate
研究概览
简要总结
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 compared to control and standard therapy, 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.
详细描述
- Introduction
1.1. Lactoferrin molecule
Lactoferrin (LF) is iron linking milk protein. LF helps to modulate iron levels in the body [1-3]. LF is a part of the milk whey protein. The colostrum (the first milk produced by mothers after delivery) has seven times more LF than mature milk [4]. LF is found in many organs like kidneys, lungs, gallbladder, pancreas, intestine, liver, prostate, and also in the body fluids like saliva, tears, sperm, cerebrospinal fluid, urine, bronchial secretions, vaginal discharge, synovial fluid, umbilical cord blood, blood plasma, and immune cells [1,2,4]. LF has many beneficial effects in the body. It has antioxidant, immunomodulatory, anti-inflammatory, antimicrobial, and antiviral effects [5]. Figure 1: different effects of lactoferrin [5]
1.2. Lactoferrin as antioxidant molecule
The body is affected by several factors such as pathogens, environmental pollutants, and toxins. This leads to the development and accumulation of reactive oxygen species (ROS) in the body which is known as oxidative stress. ROS can cause many diseases. LF can stop the harm induced by ROS [6, 7], and enhance the activity of endogenous antioxidant pathways [8].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for patients to participate in this research include adult (age ≥ 18 years) patients admitted to ICU for any reason or disease.
排除标准
- •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,
- •patients with no enteral access to administer LF either orally or by Ryle tube,
- •patients who are expected to die within 48 hours, and
- •patients with poor oral absorption as in case of shock and resected bowel.
研究组 & 干预措施
Standard
Subgroup B1 will receive standard antioxidant drug (Acetyl cysteine 600 mg / 12 hr) orally to be compared with lactoferrin A1 subgroup.
- Subgroup B2 will receive standard anti-inflammatory, and immunomodulatory drug (dexamethasone I.V 8 mg / day) to be compared with lactoferrin A2 subgroup.
- Subgroup B3 will receive standard antibacterial drugs to be compared with lactoferrin A3 subgroup.
干预措施: Dexamethasone (Drug)
Standard
Subgroup B1 will receive standard antioxidant drug (Acetyl cysteine 600 mg / 12 hr) orally to be compared with lactoferrin A1 subgroup.
- Subgroup B2 will receive standard anti-inflammatory, and immunomodulatory drug (dexamethasone I.V 8 mg / day) to be compared with lactoferrin A2 subgroup.
- Subgroup B3 will receive standard antibacterial drugs to be compared with lactoferrin A3 subgroup.
干预措施: Antibacterial therapies (Drug)
Lactoferrin
Lactoferrin 100 mg sachets with a dose of 200 mg (2 sachets) orally twice daily (400 mg per day) In addition to standard of care
干预措施: Lactoferrin (Drug)
Standard
Subgroup B1 will receive standard antioxidant drug (Acetyl cysteine 600 mg / 12 hr) orally to be compared with lactoferrin A1 subgroup.
- Subgroup B2 will receive standard anti-inflammatory, and immunomodulatory drug (dexamethasone I.V 8 mg / day) to be compared with lactoferrin A2 subgroup.
- Subgroup B3 will receive standard antibacterial drugs to be compared with lactoferrin A3 subgroup.
干预措施: Antioxidant therapies (Drug)
结局指标
主要结局
28-days mortality rate
时间窗: 28 days
Dead or alive
Number of Participants With any allergic or hypersensitivity reactions
时间窗: up to 60 days
incidence of any allergic or hypersensitivity reactions
次要结局
- Alanine Aminotransferase (ALT) concentration on day 3(day 3)
- Alanine Aminotransferase (ALT) concentration on day 7(day 7)
- Alanine Aminotransferase (ALT) concentration on day 14(day 14)
- Alanine Aminotransferase (ALT) concentration on day 28(day 28)
- Albumin concentration on day 3(day 3)
- Albumin concentration on day 7(day 7)
- Albumin concentration on day 14(day 14)
- Albumin concentration on day 28(day 28)
- White blood cells (WBCs) counts on day 3(day 3)
- White blood cells (WBCs) counts on day 7(day 7)
- White blood cells (WBCs) counts on day 14(day 14)
- White blood cells (WBCs) counts on day 28(day 28)
- Neutrophils counts on day 3(day 3)
- Neutrophils counts on day 7(day 7)
- Neutrophils counts on day 14(day 14)
- Neutrophils counts on day 28(day 28)
- Hemoglobin concentration on day 3(day 3)
- Hemoglobin concentration on day 7(day 7)
- Hemoglobin concentration on day 14(day 14)
- Hemoglobin concentration on day 28(day 28)
- Hematocrit concentration on day 3(day 3)
- Hematocrit concentration on day 7(day 7)
- Hematocrit concentration on day 14(day 14)
- Hematocrit concentration on day 28(day 28)
- Platelets counts on day 3(day 3)
- Platelets counts on day 7(day 7)
- Platelets counts on day 14(day 14)
- Platelets counts on day 28(day 28)
- Sequential Organ Function Assessment (SOFA) Score on day 3(day 3)
- Sequential Organ Function Assessment (SOFA) Score on day 7(day 7)
- Sequential Organ Function Assessment (SOFA) Score on day 14(day 14)
- Sequential Organ Function Assessment (SOFA) Score on day 28(day 28)
- Aspartate Aminotransferase (AST) concentration on day 3(day 3)
- Aspartate Aminotransferase (AST) concentration on day 7(day 7)
- Aspartate Aminotransferase (AST) concentration on day 14(day 14)
- Day of death(up to 60 days)
- Incidence of need for Invasive Mechanical Ventilation(up to 60 days)
- Oxygen Support Duration(up to 60 days)
- Duration of ICU stay(up to 60 days)
- Antioxidant marker(day 3)
- Antioxidant marker(day 7)
- Antioxidant marker(day 14)
- Antioxidant marker(day 28)
- Inflammatory marker - TNF- alpha(day 3)
- Inflammatory marker - TNF- alpha(day 7)
- Inflammatory marker - TNF- alpha(day 14)
- Inflammatory marker - TNF- alpha(day 28)
- Inflammatory marker - CRP(day 3)
- Inflammatory marker - CRP(day 7)
- Inflammatory marker - CRP(day 14)
- Inflammatory marker - CRP(day 28)
- Inflammatory marker at day 14(Bi-weekly)
- Platelets counts on day 7(day 7)
- Day of death(up to 60 days)
- Incidence of need for Invasive Mechanical Ventilation(up to 60 days)
- White blood cells (WBCs) counts on day 28(day 28)
- Neutrophils counts on day 3(day 3)
- Neutrophils counts on day 14(day 14)
- Neutrophils counts on day 28(day 28)
- Hemoglobin concentration on day 7(day 7)
- Hemoglobin concentration on day 14(day 14)
- Hematocrit concentration on day 7(day 7)
- Sequential Organ Function Assessment (SOFA) Score on day 3(day 3)
- Sequential Organ Function Assessment (SOFA) Score on day 7(day 7)
- Sequential Organ Function Assessment (SOFA) Score on day 14(day 14)
- Alanine Aminotransferase (ALT) concentration on day 3(day 3)
- Alanine Aminotransferase (ALT) concentration on day 7(day 7)
- Alanine Aminotransferase (ALT) concentration on day 14(day 14)
- Oxygen Support Duration(up to 60 days)
- Duration of ICU stay(up to 60 days)
- White blood cells (WBCs) counts on day 7(day 7)
- White blood cells (WBCs) counts on day 14(day 14)
- White blood cells (WBCs) counts on day 3(day 3)
- Neutrophils counts on day 7(day 7)
- Hemoglobin concentration on day 3(day 3)
- Hemoglobin concentration on day 28(day 28)
- Hematocrit concentration on day 3(day 3)
- Platelets counts on day 3(day 3)
- Platelets counts on day 14(day 14)
- Platelets counts on day 28(day 28)
- Sequential Organ Function Assessment (SOFA) Score on day 28(day 28)
- Aspartate Aminotransferase (AST) concentration on day 3(day 3)
- Aspartate Aminotransferase (AST) concentration on day 7(day 7)
- Aspartate Aminotransferase (AST) concentration on day 14(day 14)
- Alanine Aminotransferase (ALT) concentration on day 28(day 28)
- Albumin concentration on day 28(day 28)
- Bilirubin concentration on day 3(day 3)
- Bilirubin concentration on day 14(day 14)
- Bilirubin concentration on day 28(day 28)
- Creatinine clearance (Cr.Cl) rate on day 7(day 7)
- Hematocrit concentration on day 14(day 14)
- Hematocrit concentration on day 28(day 28)
- Aspartate Aminotransferase (AST) concentration on day 28(day 28)
- Albumin concentration on day 7(day 7)
- Albumin concentration on day 14(day 14)
- Bilirubin concentration on day 7(day 7)
- Serum Creatinine (S.Cr) concentration on day 3(day 3)
- Serum Creatinine (S.Cr) concentration on day 7(day 7)
- Creatinine clearance (Cr.Cl) rate on day 28(day 28)
- Duration of hospitalization(up to 60 days)
- Antioxidant marker at day 14(Bi-weekly)
- Antioxidant marker at day 28(Bi-weekly)
- Albumin concentration on day 3(day 3)
- Serum Creatinine (S.Cr) concentration on day 14(day 14)
- Serum Creatinine (S.Cr) concentration on day 28(day 28)
- Creatinine clearance (Cr.Cl) rate on day 3(day 3)
- Creatinine clearance (Cr.Cl) rate on day 14(day 3)
- Inflammatory marker at day 28(Bi-weekly)
研究者
Ahmed H Hassan
Principal Investigator
Mansoura University Hospital