Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU

Tanta University

Status: Completed

Conditions: Biomarkers; Acute Kidney Injury

Treatments: Diagnostic Test: ELISA test in urine

Study type: Interventional

Funder types: Other

Identifiers

NCT04554628

Security forces hospital

Details and patient eligibility

About

Early prediction of AKI can help to improve patients' outcome through early institution of the appropriate intervention, thus the current study hypothesizes that urine analysis for certain markers may provide an early knowledge about the possibility of oncoming kidney affection secondary to organ and tissue trauma affecting patients admitted to surgical ICU.

The current study tries to evaluate the value of urinary markers as early predictors of possible development of AKI in patients admitted to surgical ICU.

Full description

All patients will be clinically evaluated for demographic and clinical data. Severity of injury and number of surgical interventions will be evaluated using the simplified Therapeutic Intervention Scoring System (TISS-28) and the extent of impact of associated diseases on patients' physiological and body organs' functions will be evaluated using the Acute Physiology and Chronic Health Evaluation (APACHE II) and sequential organ failure assessment (SOFA) . Higher scores indicate more severe illness and for the TISS-28 score, each therapeutic intervention will be assigned 1 to 4 points, and the points will be summed daily to obtain the overall score and higher score indicates a higher number of therapeutic interventions.

Diagnosis of AKI Development of AKI within the first 48 hours after ICU admission and its staging will be defined according to the Acute Kidney Injury Network criteria. Each stage will be defined by the extent of change in serum creatinine level (∆SCr) as follows: Mild if Scr was increased by ≥0.3 mg/ml or ∆SCr was ≥1.5-2-fold from baseline, Moderate if ∆SCr was >2-3-fold from baseline and Severe if ∆SCr was increase by >3-fold from baseline .

Laboratory investigations Blood samples will be sent for estimation of serum creatinine (SCr) . Urine samples will be sent for spot creatinine , UNGAL, KIM1.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who were admitted to surgical ICU will be eligible for evaluation for inclusion and exclusion criteria.

Exclusion criteria

• Patients with manifest kidney disease.
• Patients had renal surgery
• Patients maintained on renal replacement therapy
• Patients had diabetic nephropathy.
• Patients had liver disease, endocrinopathies.
• Patients morbid obesity that was defined as body mass index (BMI) >35 kg/m2 .

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Urinary human neutrophil gelatinase-associated lipocalin

Active Comparator group

Description:

Urinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement

Treatment:

Diagnostic Test: ELISA test in urine

Urinary human kidney injury molecule 1 (U-KIM1)

Active Comparator group

Description:

Urinary human kidney injury molecule 1 (U-KIM1) measurement group

Treatment:

Diagnostic Test: ELISA test in urine