- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06114693
Parameters of the Recovery Time of Acute Kidney Injury in Critically Ill Patients
January 9, 2025 updated by: Mohamed abdelmongy mohamed zayed, Assiut University
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
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mohamed abdelmongy mohamed, resident
- Phone Number: 01010731630
- Email: momongy77@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
patients who admitted to the ICU for at least 24 hours and experience AKI
Description
Inclusion Criteria:
1:adult patients (age ≥ 18 years) who admitted to the ICU for at least 24 hours and experience AKI
Exclusion Criteria:
- patients (age <18 years)
- Patient who refuse enter study Patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
November 1, 2023
First Posted (Actual)
November 2, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 9, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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