Skip to main content
OpenTrials
Completed

NCT Number: NCT04554628

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Security Forces Hospital

Riyadh, 00966, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

ELISA test in urine

Diagnostic Test

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

Other names: enzyme linked immunosorbent assay technology

Primary outcomes

  1. The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.

    Time frame: 180 days

    The ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.

Secondary outcomes

  1. The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity

    Time frame: 180days

    The incidence of postoperative renal injury incidence

  2. The best detector of acute kidney injury

    Time frame: 180 days

    The results of statistical analyses for the best predictor for upcoming AKI

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2020
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.