Platelets/Albumin and AkiNCT06554977
Platelets to Albumin Ratio for Prediction of Acute Kidney Injury in Patients Admitted to the Intensive Care Unit
An observational study of Platelets/Albumin and Aki, run by Assiut University.
Trial summary
To evaluate the role of platelet to albumin ratio to detect Acute kidney injury in patients admitted to intensive care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelets/Albumin and Aki
- What is being tested?
- Laboratory
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2027
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to icu number of patients 140
Who may be able to join
- (1) Patient admitted to ICU whatever the cause ( 2) KDIGO-AKI criteria based on serum creatinine in the first 48 h of their ICU. admission
Who cannot join
- less than 18-year-old at first admission to ICU; (3) more than 10% of personal data was missing; (4) patients with repeated ICU admissions; (5) patients without serum creatinine measures between 48 and 72 h after the diagnosis of AKI (6) pregnant women . (7) patient known chronic kidney disease. (8) Patient with End stage renal disease
About this study
To evaluate the role of platelet to albumin ratio to detect Acute kidney injury in patients admitted to intensive care
Read the detailed description
Acute kidney injury (AKI) is a common clinical syndrome characterized by a sudden decline in or loss of kidney function. AKI is not only associated with substantial morbidity and mortality but also with increased risk of chronic kidney disease (CKD). AKI is classically defined and staged based on serum creatinine concentration and urine output rates. The etiology of AKI is conceptually classified into three general categories: prerenal, intrarenal, and postrenal Acute kidney injury (AKI) is a complex systemic syndrome associated with high morbidity and mortality. Among critically ill patients admitted to intensive care units (ICUs), the incidence of AKI is as high as 50% and is associated with dismal outcomes. Thus, the development and validation of clinical risk prediction tools that accurately identify patients at high risk for AKI in the ICU is of paramount importance Since the 2017 Acute Disease Quality Initiative (ADQI) workgroup proposed standard definitions of transient and persistent AKI (pAKI) based on the potential impact of AKI duration on outcomes numerous investigators explored the outcomes of different types of AKI. Previous evidence indicated that two-thirds of patients with AKI resolve their renal dysfunction rapidly and there still almost one-third of patients progress to pAKI. pAKI patients exhibited an increased risk of CKD, ESKD, prone to receive RRT, and reduced survival compared to those transient AKI patients Considering the important role of pAKI in the prognosis of critically ill patients, early and accurate risk assessment is of critical importance for clinical management in ICU patients to receive early interventions. Clinicians are seeking clinically meaningful predictors or biomarkers for pAKI in ICU patients. A recent study intended to assess novel candidate biomarkers to predict pAKI in critically ill patients and found that urinary C-C motif chemokine ligand 14 is a predictive biomarker for pAKI in critically ill patients Shen et al. reported that 24-h procalcitonin change is a good predictor of pAKI in critical patients However, these biomarkers are not easily obtained upon admission to clinical. A simple and easily accessible prognostic biomarker for early risk stratification of pAKI in patients admitted to ICU is needed. Platelet to albumin ratio (PAR) is a widely used biomarker clinically based on routine laboratory tests which reflect the systemic inflammatory state and nutrition status, has been reported to predict several disease settings
- Conditions
- Platelets/Albumin and Aki
- Being tested
- Laboratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaboratoryOther
CBC Kidney function (Urea, creatine) Platelets to albumin ratio Albumin /creatine ratio CRP Urine analysis Abdominal us Kidney function , CBC , Albumin will be done at the time of admission i
| Study group | Role | What they receive |
|---|---|---|
| Patient with Aki | acute kidney injury that will be divided into transient and persistent Aki according to follow up within 48hr and 72hr with kidney function (urea \& creatine) Receives: Other: Laboratory | |
| Non Aki patients | Not described Receives: Other: Laboratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect relation between platelets to albumin ratio for prediction of transient or persistent AKI in ICU patients
T he included patients will be divided into two groups according to the optimal cut-off value of
PAR: high-PAR group (≥ 7.2), low-PAR group (< 7.2). Number of patients is 140
Measured: 2years
Secondary outcomes (1)
Effect of the cause of ICU admission on platelets to albumin ratio and persistent AKI
- Relation between platelets to albumin ratio to hospital stay 2- Relation of platelets to albumin ratio to the need for ranel replacement therapy
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelets/Albumin and AkiStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohammed Hussein Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554977
- Sponsor's protocol ID
- Aki in icu patients
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets to Albumin Ratio for Prediction of Acute Kidney Injury in Patients Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06554977
- Acronym / sponsor ID
- Aki in icu patients
- Conditions
- Platelets/Albumin and Aki
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Aug 2024 (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.
To evaluate the role of platelet to albumin ratio to detect Acute kidney injury in patients admitted to intensive care
Detailed description
Acute kidney injury (AKI) is a common clinical syndrome characterized by a sudden decline in or loss of kidney function. AKI is not only associated with substantial morbidity and mortality but also with increased risk of chronic kidney disease (CKD). AKI is classically defined and staged based on serum creatinine concentration and urine output rates. The etiology of AKI is conceptually classified into three general categories: prerenal, intrarenal, and postrenal Acute kidney injury (AKI) is a complex systemic syndrome associated with high morbidity and mortality. Among critically ill patients admitted to intensive care units (ICUs), the incidence of AKI is as high as 50% and is associated with dismal outcomes. Thus, the development and validation of clinical risk prediction tools that accurately identify patients at high risk for AKI in the ICU is of paramount importance Since the 2017 Acute Disease Quality Initiative (ADQI) workgroup proposed standard definitions of transient and persistent AKI (pAKI) based on the potential impact of AKI duration on outcomes numerous investigators explored the outcomes of different types of AKI. Previous evidence indicated that two-thirds of patients with AKI resolve their renal dysfunction rapidly and there still almost one-third of patients progress to pAKI. pAKI patients exhibited an increased risk of CKD, ESKD, prone to receive RRT, and reduced survival compared to those transient AKI patients Considering the important role of pAKI in the prognosis of critically ill patients, early and accurate risk assessment is of critical importance for clinical management in ICU patients to receive early interventions. Clinicians are seeking clinically meaningful predictors or biomarkers for pAKI in ICU patients. A recent study intended to assess novel candidate biomarkers to predict pAKI in critically ill patients and found that urinary C-C motif chemokine ligand 14 is a predictive biomarker for pAKI in critically ill patients Shen et al. reported that 24-h procalcitonin change is a good predictor of pAKI in critical patients However, these biomarkers are not easily obtained upon admission to clinical. A simple and easily accessible prognostic biomarker for early risk stratification of pAKI in patients admitted to ICU is needed. Platelet to albumin ratio (PAR) is a widely used biomarker clinically based on routine laboratory tests which reflect the systemic inflammatory state and nutrition status, has been reported to predict several disease settings
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Aki | – | Other: Laboratoryacute kidney injury that will be divided into transient and persistent Aki according to follow up within 48hr and 72hr with kidney function (urea \& creatine) |
| Non Aki patients | – | Other: Laboratory |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to icu number of patients 140
Key inclusion criteria (1 listed)
- (1) Patient admitted to ICU whatever the cause ( 2) KDIGO-AKI criteria based on serum creatinine in the first 48 h of their ICU. admission
Key exclusion criteria (1 listed)
- less than 18-year-old at first admission to ICU; (3) more than 10% of personal data was missing; (4) patients with repeated ICU admissions; (5) patients without serum creatinine measures between 48 and 72 h after the diagnosis of AKI (6) pregnant women . (7) patient known chronic kidney disease. (8) Patient with End stage renal disease
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 |
|---|---|---|
| LaboratoryCBC Kidney function (Urea, creatine) Platelets to albumin ratio Albumin /creatine ratio CRP Urine analysis Abdominal us Kidney function , CBC , Albumin will be done at the time of admission i | Other | Non Aki patients, Patient with Aki |
Primary outcome
Detect relation between platelets to albumin ratio for prediction of transient or persistent AKI in ICU patients
Time frame: 2years
T he included patients will be divided into two groups according to the optimal cut-off value of PAR: high-PAR group (≥ 7.2), low-PAR group (< 7.2). Number of patients is 140
1 secondary outcome
Effect of the cause of ICU admission on platelets to albumin ratio and persistent AKI
Time frame: 2years
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 15 Aug 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelets/Albumin and Aki, 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 1 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 15 Aug 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect relation between platelets to albumin ratio for prediction of transient or persistent AKI in ICU patients (time frame: 2years). 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 15 Aug 2024.