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

NCT ID: NCT04554628

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-14

Study Completion Date

2020-12-10

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Biomarkers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Urinary human neutrophil gelatinase-associated lipocalin

Urinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement

Group Type ACTIVE_COMPARATOR

ELISA test in urine

Intervention Type DIAGNOSTIC_TEST

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

Urinary human kidney injury molecule 1 (U-KIM1)

Urinary human kidney injury molecule 1 (U-KIM1) measurement group

Group Type ACTIVE_COMPARATOR

ELISA test in urine

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ELISA test in urine

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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enzyme linked immunosorbent assay technology

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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MOHAMMED FAWZI ALI ABOSAMAK

lecturer of anesthesia and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Abosamak

Role: PRINCIPAL_INVESTIGATOR

Security Forces Hospital

Locations

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Security Forces Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Security forces hospital

Identifier Type: -

Identifier Source: org_study_id

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