Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563089
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Hypoalbuminemia in Critically Sick Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hypoalbuminemia in Critically Sick Children at Assiut University Childrens Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 primary outcome in this Hospital-based study is to correlate the significance of hypoalbuminemia with different prognosis and outcome of different pediatric diseases
The secondary outcomes of this study are i to investigate the frequency of occurrence of hypoalbuminemia ii to evaluate whether hypoalbuminemia on admission is a marker of adverse outcome in this population iii whether correction of albumin by Human Albumin infusion or FFP helps in decreasing the length of stay in pediatric care unit morbidity eg duration of ventilator use or mortality of the sick child
The secondary outcomes of this study are i to investigate the frequency of occurrence of hypoalbuminemia ii to evaluate whether hypoalbuminemia on admission is a marker of adverse outcome in this population iii whether correction of albumin by Human Albumin infusion or FFP helps in decreasing the length of stay in pediatric care unit morbidity eg duration of ventilator use or mortality of the sick child
Detailed Description:
Serum albumin plays an essential role by maintaining intravascular oncotic pressure and facilitating the transport of many hormones drugs and bioactive elements in blood circulation Furthermore several previous studies showed other functions of albumin such as antioxidant effects inhibition of platelet aggregation anti-inflammatory and anti-apoptotic effects Hypoalbuminemia is a frequent and early biochemical derangement in critically ill-patients Hypoalbuminemia was defined as an albumin level of less than 34 gdL for patients 7 months or older and less than 25 gdL for patients younger than 7 months Awais et al categorized hypoalbunemia to mild hypoalbuminemia patients with serum albumin levels of 33 to 34 gdL mild-moderate hypoalbuminemia serum albumin levels of 31 to 32 gdL moderate-severe hypoalbuminemia serum albumin levels of 28 to 30 gdL and severe hypoalbuminemia serum albumin levels of 12 to 27 gdL The etiology of hypoalbuminemia is complex In general it is ascribed to diminished synthesis in malnutrition malabsorption and hepatic dysfunction or increased losses in nephropathy or protein-losing enteropathy Inflammatory disorders can accelerate the catabolism of albumin while simultaneously decreasing its production Diversion of synthetic capacity to other proteins acute-phase reactants is another likely cause of hypoalbuminemia in critically ill-patients During critical illness capillary permeability increases dramatically and alters albumin exchange between intravascular and extravascular compartments Hypoalbuminemia in patients is a marker of disease severity and has been associated with prolonged ventilatory dependence and length of intensive care stay It is also an independent predictor of mortality and it is associated with poor outcome in critically ill-patients There is a paucity of data evaluating serum albumin levels and outcome of critically ill-children admitted to intensive care unit ICU The goal will be to evaluate whether hypoalbuminemia on admission is a marker of adverse outcome
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