Comparison of Intralipid With SMOF Lipid Following HSCT

Shahid Beheshti University

Status: Enrolling

Conditions: Leukemia; HSCT

Treatments: Dietary Supplement: SMOF lipid; Dietary Supplement: INTRALIPIDS

Study type: Interventional

Funder types: Other

Identifiers

NCT06625372

0311.212

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

SMOF lipid

Experimental group

Description:

The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.

Treatment:

Dietary Supplement: SMOF lipid

Intralipid

Active Comparator group

Description:

intralipids

Treatment:

Dietary Supplement: INTRALIPIDS