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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542927
• Other study ID #: 541/2022
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2022
• Source: Ain Shams University
• Contact: Abdel Rahman E Mahmoud, M.B.B.CH
• Phone: 01000996992
• Email: dr.abdelrahmanelshafei[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• urine chloride
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

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Ain shams university.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerdá 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuarcy of urinary chloride for incidence of AKI	correlation between urinary chloride concentrations and incidence of AKI.	10 days
Secondary	28-day mortality	correlation between urinary chloride concentrations and mortality of AKI patients.	28 days