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

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.

Study Overview

• Status: Completed
• Conditions: Biomarkers; Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: ELISA test in urine

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 00966
    • Security Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Urinary human neutrophil gelatinase-associated lipocalin; Urinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement	Diagnostic test: ELISA test in urine; enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients; Other Names: enzyme linked immunosorbent assay technology
Active Comparator: Urinary human kidney injury molecule 1 (U-KIM1); Urinary human kidney injury molecule 1 (U-KIM1) measurement group	Diagnostic test: ELISA test in urine; enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients; Other Names: enzyme linked immunosorbent assay technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The best detector of acute kidney injury	The results of statistical analyses for the best predictor for upcoming AKI	180 days

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohammed Abosamak, Security Forces Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2019
• Primary Completion (Actual): September 3, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: Security forces hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No