Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU
Primary Purpose
Acute Kidney Injury, Biomarkers
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
ELISA test in urine
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Kidney Injury
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 .
Sites / Locations
- Security Forces Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Urinary human neutrophil gelatinase-associated lipocalin
Urinary human kidney injury molecule 1 (U-KIM1)
Arm Description
Urinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement
Urinary human kidney injury molecule 1 (U-KIM1) measurement group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
The best detector of acute kidney injury
The results of statistical analyses for the best predictor for upcoming AKI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04554628
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2019 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urinary human neutrophil gelatinase-associated lipocalin
Arm Type
Active Comparator
Arm Description
Urinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement
Arm Title
Urinary human kidney injury molecule 1 (U-KIM1)
Arm Type
Active Comparator
Arm Description
Urinary human kidney injury molecule 1 (U-KIM1) measurement group
Intervention Type
Diagnostic Test
Intervention Name(s)
ELISA test in urine
Other Intervention Name(s)
enzyme linked immunosorbent assay technology
Intervention Description
enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients
Primary Outcome Measure Information:
Title
The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.
Description
The ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity
Description
The incidence of postoperative renal injury incidence
Time Frame
180days
Title
The best detector of acute kidney injury
Description
The results of statistical analyses for the best predictor for upcoming AKI
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abosamak
Organizational Affiliation
Security Forces Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
ZIP/Postal Code
00966
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU
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