Hypoalbuminemia in Critically Sick Children

NCT ID: NCT06563089

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2026-03-31

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.

Conditions

Hypoalbuminemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

blood sampling

Albumin level in blood

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nada Mohamed Fathy

Resident Doctor, 71515, Assiut

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nada M Fathy

Role: CONTACT

naddafathy@gmail.com

01004345631

Yasser Farouk, Assoc Prof

Role: CONTACT

yasser.rezk@med.aun.edu.eg

01111168123

References

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Reference Type: BACKGROUND

PMID: 10075059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2858667 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11064620 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 12716714 (View on PubMed)

Other Identifiers

Hypoalbuminemia

Identifier Type: -

Identifier Source: org_study_id