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Not yet recruitingNCT06114693Updated Jan 13, 2025

Parameters of the Recovery Time of Acute Kidney Injury in Critically Ill Patients

An observational study in AKI - Acute Kidney Injury, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 85 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • AKI - Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 150 is close to the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

patients who admitted to the ICU for at least 24 hours and experience AKI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1:adult patients (age ≥ 18 years) who admitted to the ICU for at least 24 hours and experience AKI

Exclusion criteria

Exclusion Criteria:

  1. patients (age \<18 years)
  2. Patient who refuse enter study Patient
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  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

    Time frame: 1year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for May 2025, 4 months later.

Of 337 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's planned 4 months is below that.

Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 13 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2023
First posted
Nov 2, 2023
StartEst.
Jan 2025
Primary completionEst.
May 2025
CompletionEst.
Sep 2025
Last update
Jan 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06114693
Lead sponsor
Assiut University
Responsible party
Mohamed abdelmongy mohamed zayed (Director, Assiut University) — Principal investigator
First posted
Nov 2, 2023
Start date
Jan 2025 (estimated)
Primary completion
May 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Jan 13, 2025

Study contacts

mohamed abdelmongy mohamed, resident
Contact
momongy77@gmail.com
01010731630

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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