Comparison of Intralipid With SMOF Lipid Following HSCT

Last updated: October 12, 2024
Sponsor: Shahid Beheshti University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Treatment

INTRALIPIDS

SMOF lipid

Clinical Study ID

NCT06625372
0311.212
  • Ages 2-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willingness to cooperate and complete the informed consent form by the legalguardian of the child;

  • Age ≤ 18 years;

  • Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● celltransplantation;

  • 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

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, liverdysfunction, the patient will be excluded from the study.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: INTRALIPIDS
Phase:
Study Start date:
October 12, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran

    Tehran,
    Iran, Islamic Republic of

    Active - Recruiting

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