NCT06563089

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

August 17, 2024

Last Update Submit

August 23, 2024

Conditions

Hypoalbuminemia

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline

Interventions

blood samplingOTHER

Albumin level in blood

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

critically sick children with hypoalbuminemia

You may qualify if:

  • 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 .

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 9250267BACKGROUND

  • 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.

    PMID: 10075059BACKGROUND

  • 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.

    PMID: 2858667BACKGROUND

  • 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.

    PMID: 17984406BACKGROUND

  • 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.

    PMID: 11064620BACKGROUND

  • 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.

    PMID: 12616115BACKGROUND

  • 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.

    PMID: 16540951BACKGROUND

  • 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.

    PMID: 12716714BACKGROUND

MeSH Terms

Conditions

Hypoalbuminemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Nada M Fathy

CONTACT

01004345631naddafathy@gmail.com

Yasser Farouk, Assoc Prof

CONTACT

01111168123yasser.rezk@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, 71515, Assiut

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

September 15, 2024

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

August 26, 2024

Record last verified: 2024-08