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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

mohamed abdelmongy mohamed, resident contact

01010731630

momongy77@gmail.com

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:

  1. to identify outcomes of critically ill patients who experienced AKI
  2. Examine the relationship between demographic and clinical variables (e.g., age, gender, comorbidities) and outcome of AKI patient
  3. 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
  4. 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.

Medical subject headings
Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted2 Nov 2023
  2. Study startJan 2025 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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)
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

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.

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