NGAL in Prediction of AKI and Patient Outcomes

NCT06691607 | Completed

• 1 other identifier: Soh-Med-23-01-31
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center prospective non-randomized observational research included 120 critically ill persons, at Sohag University hospital's critical care unit. NGAL serum level was assessed at admission to the intensive care unit (NGAL1) and 24 hours after first sample (NGAL2). Cases were categorized into two groups depending on their progression or not to AKI, group A or group B respectively during their intensive care unit stay. Serum NGAL1 and NGAL2 concentrations were compared in relation to development of AKI (group A) or not (group B), need for RRT or not and in relation to mortality.

Conditions

To Determine If Blood Level (NGAL) Could Accurately Early Detect Acute Renal Damage in All Patients Requiring Critical Care

Keywords

Critically ill, neutrophil gelatinase-associated lipocalin, acute kidney injury.

Outcome Measures

Primary Outcomes (1)

• the capability of serum NGAL levels to identify renal damage early in all patients requiring critical care

  the capability of serum NGAL levels to identify renal damage early in all patients requiring critical care

  through study completion, an average of 1 year

Secondary Outcomes (1)

• detection of patient outcome either; the need to RRT or patient mortality.

  through study completion, an average of 1 year

Study Arms (2)

Group A

Group A progressed to AKI

Other: Serum NGAL level

Group B

Group B did not progress to AKI

Other: Serum NGAL level

Interventions

Serum NGAL level OTHER

serum NGAL level

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All included patients were subjected to the following: History taking, demographic data, full medical history before ICU admission. Complete clinical examination immediately on admission. NGAL was measured by (ELISA) at admission and after 24 hours. Serum level of creatinine was measured immediately on admission and every 24 hours. Routine Laboratory investigations, abdominal ultrasound comment on kidney echogenicity was performed. Utilizing the RIFLE-SCr method, participants were split into two groups: group A that advanced acute kidney injury or failure during their intensive care unit stay, and group B that didn't. Patients with AKI should consider dialysis if they have been indicated.

You may qualify if:

• \- All severely sick ICU patients older than 18 years old were included in the study

You may not qualify if:

• Patients with known chronic renal disease, those receiving hemodialysis, those with transplanted kidney, those with known kidney cancer, and patients who were just released from the ICU

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, Egypt

Location

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: April 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)