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NCT Number: NCT06563089

Hypoalbuminemia in Critically Sick Children

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients with Severe sepsis, Respiratory diseases, Neurological diseases, Cardiac diseases, Blood diseases and gastrointestinal diseases with low albumin level .

Exclusion criteria

  • Immune deficiency patients
  • Malabsorption syndrome patients
  • Celiac disease patients
  • Protein loosing enteropathy patients
  • Nephrotic syndrome patients
  • Chronic liver disease patients

Treatment and study plan

Blood sampling

Other

Albumin level in blood

Primary outcomes

  1. to correlate the significance of hypoalbuminemia with different prognosis and outcome of different pediatric diseases. 5

    Time frame: Baseline

    To evaluate whether hypoalbuminemia is a predictor of adverse outcome in different disease

Study contacts

Contact information is provided by the study sponsor or research team.

Nada M Fathy

CONTACT

[email protected]

01004345631

Yasser Farouk, Assoc Prof

CONTACT

[email protected]

01111168123

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Hypoalbuminemia in Critically Sick Children at Assiut University Children's Hospital

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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