Comparison of Intralipid With SMOF Lipid Following HSCT

Not Applicable

Recruiting

• Conditions: Leukemia; HSCT

• Registration Number: NCT06625372
• Lead Sponsor: Shahid Beheshti University

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 \>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.

Study Timeline

• Study First Submitted: 2024-09-28
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-10-12
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Engraftment	Within 35 days after transplantation	blood counts of Neutrophils and platelets

Secondary Outcome Measures

Name	Time	Method
100-day survival rate	Within 100 days after transplantation	Determination and comparison of 100-day survival rate after transplantation in both groups
Incidence of infection	Within 30 days after transplant	Determining and comparing the incidence of infection
Incidence of bleeding	Within 30 days after transplantation	Determining and comparing the incidence of bleeding
Hospitalization	up to 7 weeks after transplantation	Determining and comparing the duration of hospitalization in both groups
Mortality	up to 7 weeks after transplantation	incidence of mortality in hospital
MAC (mid arm circumference)	On days 15 and 30 after transplantation	Determination and comparison of MAC in both groups
Albumin	On days 15 and 30 after transplantation	Determination and comparison of serum albumin
Acute gastrointestinal complications	Up to 100 days after transplantation	Determining and comparing the incidence of acute gastrointestinal complications (including acute GVHD, cholestasis) in both groups.
Duration of parenteral nutrition	during hospitalization, up to 7 weeks after transplantation	Determining and comparing the duration of using parenteral nutrition
Weight	On days 15 and 30 after transplantation	Determination and comparison of weight in both groups
Blood sugar	On days 15 and 30 after transplantation	Determination and comparison of blood sugar,
Serum electrolytes	On days 15 and 30 after transplantation	Determination and comparison of serum electrolytes
Serum lipids	On days 15 and 30 after transplantation	Determination and comparison of serum lipids
Serum Interleukin 6 (IL-6)	On days 15 and 30 after transplantation	Determination of serum interleukin 6 (IL-6)

Trial Locations

Locations (1)

Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran; 🇮🇷 Tehran, Iran, Islamic Republic of