Incidence of Acute Kidney Injury and Mortality in Critically Ill Patients: Urinary Chloride as a Prognostic Marker
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Abdel Rahman E Mahmoud, M.B.B.CH
- Phone Number: 002 01000996992
- Email: dr.abdelrahmanelshafei@gmail.com
Study Contact Backup
- Name: Wael E Mohamed, MD
- Phone Number: 002 01224576517
Study Locations
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Cairo, Egypt
- Recruiting
- Faculty of Medicine, Ain Shams University.
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Contact:
- Abdel Rahman E Mahmoud, MBBCH
- Phone Number: 01000996992
- Email: dr.abdelrahmanelshafei@gmail.com
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Contact:
- Wael E Mohamed, MD
- Phone Number: 01224576517
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Critically ill Acute kidney injury patients
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)
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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diagnostic accuarcy of urinary chloride for incidence of AKI
Time Frame: 10 days
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correlation between urinary chloride concentrations and incidence of AKI.
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10 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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28-day mortality
Time Frame: 28 days
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correlation between urinary chloride concentrations and mortality of AKI patients.
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28 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0.
- Kellum JA, Prowle JR. Paradigms of acute kidney injury in the intensive care setting. Nat Rev Nephrol. 2018 Apr;14(4):217-230. doi: 10.1038/nrneph.2017.184. Epub 2018 Jan 22.
- Abd ElHafeez S, Tripepi G, Quinn R, Naga Y, Abdelmonem S, AbdelHady M, Liu P, James M, Zoccali C, Ravani P. Risk, Predictors, and Outcomes of Acute Kidney Injury in Patients Admitted to Intensive Care Units in Egypt. Sci Rep. 2017 Dec 7;7(1):17163. doi: 10.1038/s41598-017-17264-7.
- Yunos NM, Bellomo R, Story D, Kellum J. Bench-to-bedside review: Chloride in critical illness. Crit Care. 2010;14(4):226. doi: 10.1186/cc9052. Epub 2010 Jul 8.
- Neyra JA, Canepa-Escaro F, Li X, Manllo J, Adams-Huet B, Yee J, Yessayan L; Acute Kidney Injury in Critical Illness Study Group. Association of Hyperchloremia With Hospital Mortality in Critically Ill Septic Patients. Crit Care Med. 2015 Sep;43(9):1938-44. doi: 10.1097/CCM.0000000000001161.
- Sadan O, Singbartl K, Kandiah PA, Martin KS, Samuels OB. Hyperchloremia Is Associated With Acute Kidney Injury in Patients With Subarachnoid Hemorrhage. Crit Care Med. 2017 Aug;45(8):1382-1388. doi: 10.1097/CCM.0000000000002497.
- Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 541/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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