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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554628
• Other study ID #: Security forces hospital
• Status: Completed
• Phase: N/A
• Start date: September 14, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: March 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 10, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Acute Kidney Injury
• Biomarkers
• Wounds and Injuries

Intervention

Diagnostic Test:
• ELISA test in urine
enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.	The ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.	180 days
Secondary	The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity	The incidence of postoperative renal injury incidence	180days
Secondary	The best detector of acute kidney injury	The results of statistical analyses for the best predictor for upcoming AKI	180 days