Acute Kidney InjuryNCT05542927
Incidence of Acute Kidney Injury and Mortality in Critically Ill Patients: Urinary Chloride as a Prognostic Marker
An observational study of Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- urine chloride
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Mar 2023
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Adult, Older adult
Study population: Critically ill patients diagnosed with AKI
Who may be able to join
- Age from 21 years old and above.
- No history of chronic kidney disease (CKD).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Wael E Mohamed, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Ain shams university.
Cairo
Abdel Rahman E Mahmoud, MBBCH, 01000996992, dr.abdelrahmanelshafei@gmail.com
Wael E Mohamed, MD, 01224576517
About this study
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.
- Conditions
- Acute Kidney Injury
- Being tested
- urine chloride
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine chlorideDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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)
1. Serum chloride, urinary chloride \& serum creatinine will be requested on the first day of admission in 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 every 24 hours.
5. Daily SOFA score. Receives: Diagnostic Test: urine chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuarcy of urinary chloride for incidence of AKI
correlation between urinary chloride concentrations and incidence of AKI.
Measured: 10 days
Secondary outcomes (1)
28-day mortality
correlation between urinary chloride concentrations and mortality of AKI patients.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Sep 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman El shafei, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542927
- Sponsor's protocol ID
- 541/2022
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
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.
PubMed 29355173Abd 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.
PubMed 29215080Hoste 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.
PubMed 30135570Yunos 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.
PubMed 20663180Neyra 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.
PubMed 26154934Sadan 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.
PubMed 28504980Semler 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.
PubMed 29485925
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Kidney Injury and Mortality in Critically Ill Patients: Urinary Chloride as a Prognostic Marker
- ClinicalTrials.gov ID
- NCT05542927
- Acronym / sponsor ID
- 541/2022
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill Acute kidney injury patients | – | Diagnostic Test: urine chlorideAKI 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) 1. Serum chloride, urinary chloride \& serum creatinine will be requested on the first day of admission in 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 every 24 hours. 5. Daily SOFA score. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients diagnosed with AKI
Key inclusion criteria (2 listed)
- Age from 21 years old and above.
- No history of chronic kidney disease (CKD).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine chlorideSerum 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 | Diagnostic test | Critically ill Acute kidney injury patients |
Primary outcome
diagnostic accuarcy of urinary chloride for incidence of AKI
Time frame: 10 days
correlation between urinary chloride concentrations and incidence of AKI.
1 secondary outcome
28-day mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 29355173Kellum 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.
- Background: PubMed 29215080Abd 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.
- Background: PubMed 30135570Hoste 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.
- Background: PubMed 20663180Yunos 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.
- Background: PubMed 26154934Neyra 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.
- Background: PubMed 28504980Sadan 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.
- Background: PubMed 29485925Semler 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.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael E Mohamed, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdel Rahman E Mahmoud, M.B.B.CH (01000996992 ext. 002, dr.abdelrahmanelshafei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuarcy of urinary chloride for incidence of AKI (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542927, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.