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

NCT04554628 | Completed

• 1 other identifier: Security forces hospital
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  180days

• The best detector of acute kidney injury

  180 days

Study Arms (2)

Urinary human neutrophil gelatinase-associated lipocalin

ACTIVE COMPARATOR

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

Diagnostic Test: ELISA test in urine

Urinary human kidney injury molecule 1 (U-KIM1)

ACTIVE COMPARATOR

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

Diagnostic Test: ELISA test in urine

Interventions

ELISA test in urine DIAGNOSTIC_TEST

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

Also known as: enzyme linked immunosorbent assay technology

Urinary human kidney injury molecule 1 (U-KIM1); Urinary human neutrophil gelatinase-associated lipocalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Security Forces Hospital

Riyadh, 00966, Saudi Arabia

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Urination

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Mohammed Abosamak

  Security Forces Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 18, 2020
• Study Start: September 14, 2019
• Primary Completion: September 3, 2020
• Study Completion: December 10, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SA (1)