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Recruiting NCT06625372

Comparison of Intralipid With SMOF Lipid Following HSCT

No phase Interventional Leukemia HSCT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SMOF lipid, INTRALIPIDS.
Who it may be relevant to
Registry conditions: Leukemia, HSCT. Basic parameters: 2 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iran
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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 \>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.

Interventions

  • Dietary supplement SMOF lipid
    The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
  • Dietary supplement INTRALIPIDS
    The Intralipid will be given to the patient as fat component of total parenteral nutrition.

Primary outcome measures

  • Engraftment [Time frame: Within 35 days after transplantation]
Secondary outcome measures (12)
  • 100-day survival rate [Time frame: Within 100 days after transplantation]
  • Incidence of infection [Time frame: Within 30 days after transplant]
  • Incidence of bleeding [Time frame: Within 30 days after transplantation]
  • Hospitalization [Time frame: up to 7 weeks after transplantation]
  • Mortality [Time frame: up to 7 weeks after transplantation]
  • MAC (mid arm circumference) [Time frame: On days 15 and 30 after transplantation]
  • Albumin [Time frame: On days 15 and 30 after transplantation]
  • Acute gastrointestinal complications [Time frame: Up to 100 days after transplantation]
  • Duration of parenteral nutrition [Time frame: during hospitalization, up to 7 weeks after transplantation]
  • Weight [Time frame: On days 15 and 30 after transplantation]
  • Blood sugar [Time frame: On days 15 and 30 after transplantation]
  • Serum electrolytes [Time frame: On days 15 and 30 after transplantation]

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 \> 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Iran · 1 center
  • Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical S — Tehran

Identifiers

NCT: NCT06625372 · 0311.212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗