Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625372
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Comparison of Intralipid With SMOF Lipid Following HSCT
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ampgt500 for neutrophils and ampgt20000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None