Incidence of Acute Kidney Injury and Mortality in Critically Ill Patients: Urinary Chloride as a Prognostic Marker

Study Overview
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Brief Summary
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Acute kidney injury (AKI) is characterized by a rapid decrease in renal function. It is frequent in hospitalized patients and its incidence is higher in critically ill patients. It is associated with high rates of morbidity and mortality. AKI affects over 13 million people per year globally, and results in 1.7 million deaths. It is diagnosed in up to 20% of hospitalized patients and in 30- 60% of critically ill patients. It is the most frequent cause of organ dysfunction in intensive care units and the occurrence of even mild AKI is associated with a 50% higher risk of death. AKI has been associated with longer hospital stays, in-hospital mortality, cardiovascular events, progression to chronic kidney disease and long-term mortality. It results in a significant burden for the society in terms of health resource use during the acute phase and the potential long-term sequelae including development of chronic kidney disease and kidney failure. Yunos et al. have focused on chloride, which is the most abundant strong anion in extracellular fluid. Progression of hyperchloremia in the ICU was identified as a predictor of increased mortality in a large retrospective cohort study of critically ill septic patients. Sadan et al. have shown associations between hyperchloremia and an increased incidence of AKI in patients with subarachnoid hemorrhage, as well as in patients who have undergone abdominal surgery. Abnormal blood chloride concentrations were associated with metabolic acidosis, which may worsen patient outcomes. Moreover, hyperchloremia may be caused by inappropriate fluid management with chloride-rich solutions. Importantly, chloride-rich solutions were reportedly associated with hyperchloremia and major adverse kidney disease, including death, in intensive care settings. Urine samples are relatively easy to collect in ICU, and real-time urinary electrolyte monitoring device is available for clinical use. In addition, recent development of urinary AKI biomarkers has enabled clinical evaluation of kidney function. Komaru et al. examined associations among urinary chloride, mortality, and AKI incidence in ICU patients and concluded that lower urinary chloride concentration was associated with increased mortality and incidence of AKI in the ICU.

Official Title
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Incidence of Acute Kidney Injury and Mortality in Critically Ill Patients: Urinary Chloride as a Prognostic Marker

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Diagnostic Test: urine chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 21 years old and above. No history of chronic kidney disease (CKD). Exclusion Criteria: Age under 21 years old. Patients leaving the ICU within 24 hours for any reason. Anuric patients. Patients on maintenance hemodialysis. Patients those without day 1 urinary or blood tests. Refusal of patient or his/her relative participation in the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill Acute kidney injury patients<br>AKI is defined as any of the following: Increase in SCr by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR increase in SCr to≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR Urine volume <0.5 ml/kg/h for 6 hour) Serum chloride, urinary chloride & serum creatinine will be requested on the first day of admission in ICU Serum chloride & urinary chloride will be requested every 48 hours in ICU with correlation between urinary chloride concentrations, AKI & mortality. Serum creatinine will be requested every 24 hours in ICU. Monitoring of Urinary Output every 24 hours. Daily SOFA score. | Diagnostic Test: urine chloride<br>* Serum chloride, urinary chloride & serum creatinine will be requested on the first day of admission in Intensive Care Unit (ICU). 2. Serum chloride & urinary chloride will be requested every 48 hours in ICU with correlation between urinary chloride concentrations, AKI & mortality. 3. Serum creatinine will be requested every 24 hours in ICU. 4. Monitoring of Urinary Output (U.O.P.) every 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuarcy of urinary chloride for incidence of AKI | correlation between urinary chloride concentrations and incidence of AKI. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | correlation between urinary chloride concentrations and mortality of AKI patients. | 28 days |