Clinical trial NCT06625372: Comparison of Intralipid With SMOF Lipid Following HSCT
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
HSCT
Keywords: mortality
SMOF
Intralipid
Engrafment
Complications
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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 \&amp;gt;500 for neutrophils and \&amp;gt;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.

Eligibility criteria: 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 \&amp;gt; 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.

Primary outcomes:
measure: Engraftment
timeFrame: Within 35 days after transplantation
Secondary outcomes:
measure: 100-day survival rate
timeFrame: Within 100 days after transplantation
measure: Incidence of infection
timeFrame: Within 30 days after transplant
measure: Incidence of bleeding
timeFrame: Within 30 days after transplantation
measure: Hospitalization
timeFrame: up to 7 weeks after transplantation
measure: Mortality
timeFrame: up to 7 weeks after transplantation
measure: MAC (mid arm circumference)
timeFrame: On days 15 and 30 after transplantation
measure: Albumin
timeFrame: On days 15 and 30 after transplantation
measure: Acute gastrointestinal complications
timeFrame: Up to 100 days after transplantation
measure: Duration of parenteral nutrition
timeFrame: during hospitalization, up to 7 weeks after transplantation
measure: Weight
timeFrame: On days 15 and 30 after transplantation
measure: Blood sugar
timeFrame: On days 15 and 30 after transplantation
measure: Serum electrolytes
timeFrame: On days 15 and 30 after transplantation
measure: Serum lipids
timeFrame: On days 15 and 30 after transplantation
measure: Serum Interleukin 6 (IL-6)
timeFrame: On days 15 and 30 after transplantation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran
Study officials:
affiliation: School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
name: Zahra Vahdat Shariatpanahi, Professor
role: PRINCIPAL_INVESTIGATOR
References: