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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04554628
Enrollment
200
Registered
2020-09-18
Start date
2019-09-14
Completion date
2020-12-10
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Biomarkers

Brief summary

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTELISA test in urine

enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients who were admitted to surgical ICU will be eligible for evaluation for inclusion and

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.180 daysThe ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.

Secondary

MeasureTime frameDescription
The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity180daysThe incidence of postoperative renal injury incidence
The best detector of acute kidney injury180 daysThe results of statistical analyses for the best predictor for upcoming AKI

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026