AKI - Acute Kidney InjuryNCT06114693
Parameters of the Recovery Time of Acute Kidney Injury in Critically Ill Patients
An observational study of AKI - Acute Kidney Injury, run by Assiut University.
Trial summary
the primary objective of this study is to identify and analyze parametrers affecting the time of recovery of AKI in critical ill patient ,Specifically, the study aims to: 1. to identify outcomes of critically ill patients who experienced AKI 2. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- AKI - Acute Kidney Injury
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who admitted to the ICU for at least 24 hours and experience AKI
Who may be able to join
- 1:adult patients (age ≥ 18 years) who admitted to the ICU for at least 24 hours and experience AKI
Who cannot join
- patients (age <18 years)
- Patient who refuse enter study Patient
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
the primary objective of this study is to identify and analyze parametrers affecting the time of recovery of AKI in critical ill patient ,Specifically, the study aims to:
- to identify outcomes of critically ill patients who experienced AKI
- Examine the relationship between demographic and clinical variables (e.g., age, gender, comorbidities) and outcome of AKI patient
- follow Baseline characteristics and laboratory findings of the patients at the time of admission to the intensive care unit and affecting it at recovery time
- Explore the association between psychosocial factors (e.g., depression, anxiety, social support) and outcome of AKI patient at icu
Read the detailed description
cute kidney injury (AKI) is a common diagnosis in the adult intensive care unit (ICU) due to substantial short- and long-term morbidity and mortality associated with its occurence.AKI globally impacts more than 13 million patients, resulting in approximately 2 million deaths annually.In the United States, it has been estimated that up to 10% of hospi-talizations and up to 60% of patients admitted to an ICU experience AKI. AKI is an abrupt (within hours) decrease in kidney function defined as an increase in serum creatinine (SCr) or a decrease in urine output (UO) for a duration between 7 and 90 days after exposure to an AKI-causing event.The etiology is complex and routinely multifactorial. Known common risk factors associated with AKI inclde diabetes, hypertension, chronic kidney disease (CKD), cardiovascular, lung, and liver diseases, sepsis and surgical interventions, as well as exposure to nephrotoxic medications and diagnostic contrast agents.Despite the development of numerous prevention strategies, the most recent data suggest the incidence of AKI is increasing in the critically ill population.The Kidney Disease Improving Global Outcomes (KDIGO) 2012 workgroup classifies AKI into three stages based on SCr and UO values. AKI is defined within 1week after ICU admission as any of the following: increase in SCr by ⩾0.3mg/dL within 48 h, or increase in SCr to ⩾1.5 times baseline within 1week, or urine output<0.5 mL/kg/hour for 6 h. Severe AKI is defined as KDIGO stage II or stage III AKI .However, SCr and UO measurements remain the standard for evaluation, yet are insensitive and nonspecific markers of AKI and do not account for the etiology or duration of the injury. Despite consensus guidelines for the diagnosis of AKI, discrepancies remain when defining AKI upon ICU admission. Numerous factors influence SCr laboratory measurement such as gender, age, muscle mass, nutritional status, and chronic illness potentially lead-ing to inaccurate estimation of glomerular filtration rate (eGFR). Furthermore, UO can be influenced by a myriad of factors such as effective circulating volume status, hemody-namic status, and medications that impact urinary excretion. Despite current AKI staging guidelines being widely accepted, accuracy of eGFR remains challenging. The strong and independent relationship between AKI and short-term mortality is well described among ICU patients.Short-term outcomes of AKI include alterations in acid-base and electrolyte balance, uremia, and volume overload.Long-term consequences of AKI can be equally devastating and have been associated with acceleration and progression to CKD and end-stage renal disease (ESRD), resulting in the need for lifelong dialysis, renal transplantation, and an exorbitant increase in healthcare expenditures.Therefore, there is a critical need to identify high-risk patients for AKI, the impact of medication use on its incidence, recovery patterns, and clinical outcomes such as mortality, length of stay, and need for mechanical ventilation.
- Conditions
- AKI - Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
parameters as renal arterial resistive index and its effect at recovery time of aki patient at icu
comorbidities(DM,HTN,cardiac disease ) sepsis Renal arterial resistive index
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startJan 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abdelmongy mohamed zayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114693
- Sponsor's protocol ID
- AKI
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2023
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters of the Recovery Time of Acute Kidney Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06114693
- Acronym / sponsor ID
- AKI
- Conditions
- AKI - Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Nov 2023 (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.
the primary objective of this study is to identify and analyze parametrers affecting the time of recovery of AKI in critical ill patient ,Specifically, the study aims to:
- to identify outcomes of critically ill patients who experienced AKI
- Examine the relationship between demographic and clinical variables (e.g., age, gender, comorbidities) and outcome of AKI patient
- follow Baseline characteristics and laboratory findings of the patients at the time of admission to the intensive care unit and affecting it at recovery time
- Explore the association between psychosocial factors (e.g., depression, anxiety, social support) and outcome of AKI patient at icu
Detailed description
cute kidney injury (AKI) is a common diagnosis in the adult intensive care unit (ICU) due to substantial short- and long-term morbidity and mortality associated with its occurence.AKI globally impacts more than 13 million patients, resulting in approximately 2 million deaths annually.In the United States, it has been estimated that up to 10% of hospi-talizations and up to 60% of patients admitted to an ICU experience AKI. AKI is an abrupt (within hours) decrease in kidney function defined as an increase in serum creatinine (SCr) or a decrease in urine output (UO) for a duration between 7 and 90 days after exposure to an AKI-causing event.The etiology is complex and routinely multifactorial. Known common risk factors associated with AKI inclde diabetes, hypertension, chronic kidney disease (CKD), cardiovascular, lung, and liver diseases, sepsis and surgical interventions, as well as exposure to nephrotoxic medications and diagnostic contrast agents.Despite the development of numerous prevention strategies, the most recent data suggest the incidence of AKI is increasing in the critically ill population.The Kidney Disease Improving Global Outcomes (KDIGO) 2012 workgroup classifies AKI into three stages based on SCr and UO values. AKI is defined within 1week after ICU admission as any of the following: increase in SCr by ⩾0.3mg/dL within 48 h, or increase in SCr to ⩾1.5 times baseline within 1week, or urine output<0.5 mL/kg/hour for 6 h. Severe AKI is defined as KDIGO stage II or stage III AKI .However, SCr and UO measurements remain the standard for evaluation, yet are insensitive and nonspecific markers of AKI and do not account for the etiology or duration of the injury. Despite consensus guidelines for the diagnosis of AKI, discrepancies remain when defining AKI upon ICU admission. Numerous factors influence SCr laboratory measurement such as gender, age, muscle mass, nutritional status, and chronic illness potentially lead-ing to inaccurate estimation of glomerular filtration rate (eGFR). Furthermore, UO can be influenced by a myriad of factors such as effective circulating volume status, hemody-namic status, and medications that impact urinary excretion. Despite current AKI staging guidelines being widely accepted, accuracy of eGFR remains challenging. The strong and independent relationship between AKI and short-term mortality is well described among ICU patients.Short-term outcomes of AKI include alterations in acid-base and electrolyte balance, uremia, and volume overload.Long-term consequences of AKI can be equally devastating and have been associated with acceleration and progression to CKD and end-stage renal disease (ESRD), resulting in the need for lifelong dialysis, renal transplantation, and an exorbitant increase in healthcare expenditures.Therefore, there is a critical need to identify high-risk patients for AKI, the impact of medication use on its incidence, recovery patterns, and clinical outcomes such as mortality, length of stay, and need for mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who admitted to the ICU for at least 24 hours and experience AKI
Key inclusion criteria (1 listed)
- 1:adult patients (age ≥ 18 years) who admitted to the ICU for at least 24 hours and experience AKI
Key exclusion criteria (2 listed)
- patients (age <18 years)
- Patient who refuse enter study Patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
parameters as renal arterial resistive index and its effect at recovery time of aki patient at icu
Time frame: 1year
comorbidities(DM,HTN,cardiac disease ) sepsis Renal arterial resistive index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI - Acute Kidney Injury, run by Assiut University.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed abdelmongy mohamed, resident (01010731630, momongy77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parameters as renal arterial resistive index and its effect at recovery time of aki patient at icu (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025.