Comparison of the Effect of Intralipid Parenteral Nutritional With SMOF Lipid Parenteral Nutritional on Biochemical Markers, Hematologic Markers, and Clinical Outcomes Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Engraftment
研究概览
简要总结
The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.
详细描述
Patients will be randomly divided into two groups: the intervention group (TPN based on SMOFLipid) and the control group (TPN based on IntraLipid). At baseline (before HSCT) and after obtaining informed consent and assent, blood samples will be collected to test for biochemical markers, including total cholesterol, TG, LDL, HDL, FBS, Alb, Na, K, Ph, Ca, Mg, CRP, IL-6, BUN, Cr, and CBC. Furthermore, data on nutritional intake (total energy and protein) and appetite status will be gathered. The primary outcomes are neutrophil and platelet engraftment, defined as >500 for neutrophils and >20,000 for platelets, respectively. The possibility of oral intake, as well as the achievement of oral + ONS and total oral nutrition alongside TPN duration, will be recorded. On days +15 and +30, biochemical and anthropometric markers will be collected again. Furthermore, clinical outcomes such as acute GVHD, cholestasis, bleeding, infections, hospitalization, and mortality will be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to cooperate and complete the informed consent form by the legal guardian of the child;
- •Age ≤ 18 years;
- •Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation;
- •Eligible for parenteral nutrition support;
- •No contraindications for parenteral nutrition;
- •No history of allergy to egg or soy protein;
- •Absence of severe organ failure or impaired liver function test (bilirubin > 2.5 mg/dL).
排除标准
- •Death of the child earlier than 5 days from the start of the intervention;
- •Unwillingness to continue cooperation during study;
- •Occurrence of side effects during the study;
- •In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.
结局指标
主要结局
Engraftment
时间窗: Within 35 days after transplantation
blood counts of Neutrophils and platelets
次要结局
- 100-day survival rate(Within 100 days after transplantation)
- Incidence of infection(Within 30 days after transplant)
- Incidence of bleeding(Within 30 days after transplantation)
- Hospitalization(up to 7 weeks after transplantation)
- Mortality(up to 7 weeks after transplantation)
- MAC (mid arm circumference)(On days 15 and 30 after transplantation)
- Albumin(On days 15 and 30 after transplantation)
- Acute gastrointestinal complications(Up to 100 days after transplantation)
- Duration of parenteral nutrition(during hospitalization, up to 7 weeks after transplantation)
- Weight(On days 15 and 30 after transplantation)
- Blood sugar(On days 15 and 30 after transplantation)
- Serum electrolytes(On days 15 and 30 after transplantation)
- Serum lipids(On days 15 and 30 after transplantation)
- Serum Interleukin 6 (IL-6)(On days 15 and 30 after transplantation)
研究者
Zahra Vahdat Shariatpanahi
Associate professor
Shahid Beheshti University