Clinical trial NCT04554628: Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU
Official title: Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Biomarkers
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.
timeFrame: 180 days
Secondary outcomes:
measure: The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity
timeFrame: 180days
measure: The best detector of acute kidney injury
timeFrame: 180 days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
Study officials:
affiliation: Security Forces Hospital
name: Mohammed Abosamak
role: PRINCIPAL_INVESTIGATOR
References: