Clinical trial NCT06563089: Hypoalbuminemia in Critically Sick Children
Official title: Hypoalbuminemia in Critically Sick Children at Assiut University Children's Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypoalbuminemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically sick children with hypoalbuminemia

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 (e.g., 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 3.4 g/dL for patients 7 months or older and less than 2.5 g/dL for patients younger than 7 months. Awais et al. categorized hypoalbunemia to mild hypoalbuminemia (patients with serum albumin levels of 3.3 to 3.4 g/dL), mild-moderate hypoalbuminemia (serum albumin levels of 3.1 to 3.2 g/dL), moderate-severe hypoalbuminemia (serum albumin levels of 2.8 to 3.0 g/dL) and severe hypoalbuminemia (serum albumin levels of 1.2 to 2.7 g/dL). 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with an albumin level of less than 3.4 g/dL for patients 7 months or older and less than 2.5 g/dL for patients younger than 7 months.
2. Patients with Severe sepsis, Respiratory diseases, Neurological diseases, Cardiac diseases, Blood diseases and gastrointestinal diseases with low albumin level .

Exclusion Criteria:

1. Immune deficiency patients
2. Malabsorption syndrome patients
3. Celiac disease patients
4. Protein loosing enteropathy patients
5. Nephrotic syndrome patients
6. Chronic liver disease patients

Primary outcomes:
measure: to correlate the significance of hypoalbuminemia with different prognosis and outcome of different pediatric diseases. 5
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Goldwasser P, Feldman J. Association of serum albumin and mortality risk. J Clin Epidemiol. 1997 Jun;50(6):693-703. doi: 10.1016/s0895-4356(97)00015-2.
citation: Rady MY, Ryan T. Perioperative predictors of extubation failure and the effect on clinical outcome after cardiac surgery. Crit Care Med. 1999 Feb;27(2):340-7. doi: 10.1097/00003246-199902000-00041.
citation: Fleck A, Raines G, Hawker F, Trotter J, Wallace PI, Ledingham IM, Calman KC. Increased vascular permeability: a major cause of hypoalbuminaemia in disease and injury. Lancet. 1985 Apr 6;1(8432):781-4. doi: 10.1016/s0140-6736(85)91447-3.
citation: Horowitz IN, Tai K. Hypoalbuminemia in critically ill children. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1048-52. doi: 10.1001/archpedi.161.11.1048.
citation: Nicholson JP, Wolmarans MR, Park GR. The role of albumin in critical illness. Br J Anaesth. 2000 Oct;85(4):599-610. doi: 10.1093/bja/85.4.599. No abstract available.
citation: Vincent JL, Dubois MJ, Navickis RJ, Wilkes MM. Hypoalbuminemia in acute illness: is there a rationale for intervention? A meta-analysis of cohort studies and controlled trials. Ann Surg. 2003 Mar;237(3):319-34. doi: 10.1097/01.SLA.0000055547.93484.87.
citation: Zimmerman JE, Kramer AA, McNair DS, Malila FM. Acute Physiology and Chronic Health Evaluation (APACHE) IV: hospital mortality assessment for today's critically ill patients. Crit Care Med. 2006 May;34(5):1297-310. doi: 10.1097/01.CCM.0000215112.84523.F0.
citation: Durward A, Mayer A, Skellett S, Taylor D, Hanna S, Tibby SM, Murdoch IA. Hypoalbuminaemia in critically ill children: incidence, prognosis, and influence on the anion gap. Arch Dis Child. 2003 May;88(5):419-22. doi: 10.1136/adc.88.5.419.