HSCT, Leukemia
Conditions
Keywords
mortality, SMOF, Intralipid, Engrafment, Complications
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.
Interventions
DIETARY_SUPPLEMENTSMOF lipid
The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
DIETARY_SUPPLEMENTINTRALIPIDS
The Intralipid will be given to the patient as fat component of total parenteral nutrition.
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engraftment | Within 35 days after transplantation | blood counts of Neutrophils and platelets |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 100-day survival rate | Within 100 days after transplantation | Determination and comparison of 100-day survival rate after transplantation 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) |
| 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. |
Countries
Iran
Contacts
Primary ContactZahra Vahdat Shariatpanahi, Professor
Backup ContactZahra Vahdat Shariatpanahi, Professor
Outcome results
None listed