Acute Kidney InjuryNCT04554628
Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU
A study testing ELISA test in urine in people with Acute Kidney Injury and Biomarkers, run by Tanta University at 1 site in Saudi Arabia.
Trial summary
Early prediction of AKI can help to improve patients' outcome through early institution of the appropriate intervention, thus the current study hypothesizes that urine analysis for certain markers may provide an early knowledge about the possibility of oncoming kidney affection secondary to organ and tissue trauma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Biomarkers
- What is being tested?
- ELISA test in urine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 Sep 2019to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who were admitted to surgical ICU will be eligible for evaluation for inclusion and exclusion criteria.
Who cannot join
- Patients with manifest kidney disease.
- Patients had renal surgery
- Patients maintained on renal replacement therapy
- Patients had diabetic nephropathy.
- Patients had liver disease, endocrinopathies.
- Patients morbid obesity that was defined as body mass index (BMI) >35 kg/m2 .
Trial locations and contacts
1 site in 1 country.
About this study
Early prediction of AKI can help to improve patients' outcome through early institution of the appropriate intervention, thus the current study hypothesizes that urine analysis for certain markers may provide an early knowledge about the possibility of oncoming kidney affection secondary to organ and tissue trauma affecting patients admitted to surgical ICU.
The current study tries to evaluate the value of urinary markers as early predictors of possible development of AKI in patients admitted to surgical ICU.
Read the detailed description
All patients will be clinically evaluated for demographic and clinical data. Severity of injury and number of surgical interventions will be evaluated using the simplified Therapeutic Intervention Scoring System (TISS-28) and the extent of impact of associated diseases on patients' physiological and body organs' functions will be evaluated using the Acute Physiology and Chronic Health Evaluation (APACHE II) and sequential organ failure assessment (SOFA) . Higher scores indicate more severe illness and for the TISS-28 score, each therapeutic intervention will be assigned 1 to 4 points, and the points will be summed daily to obtain the overall score and higher score indicates a higher number of therapeutic interventions.
Diagnosis of AKI Development of AKI within the first 48 hours after ICU admission and its staging will be defined according to the Acute Kidney Injury Network criteria. Each stage will be defined by the extent of change in serum creatinine level (∆SCr) as follows: Mild if Scr was increased by ≥0.3 mg/ml or ∆SCr was ≥1.5-2-fold from baseline, Moderate if ∆SCr was >2-3-fold from baseline and Severe if ∆SCr was increase by >3-fold from baseline .
Laboratory investigations Blood samples will be sent for estimation of serum creatinine (SCr) . Urine samples will be sent for spot creatinine , UNGAL, KIM1.
- Conditions
- Acute Kidney Injury, Biomarkers
- Being tested
- ELISA test in urine
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA test in urineDiagnostic test
Also called enzyme linked immunosorbent assay technology
enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients
| Study group | Role | What they receive |
|---|---|---|
| Urinary human neutrophil gelatinase-associated lipocalin | Active comparator | Urinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement Receives: Diagnostic Test: ELISA test in urine |
| Urinary human kidney injury molecule 1 (U-KIM1) | Active comparator | Urinary human kidney injury molecule 1 (U-KIM1) measurement group Receives: Diagnostic Test: ELISA test in urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.
The ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.
Measured: 180 days
Secondary outcomes (2)
The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity
The incidence of postoperative renal injury incidence
Measured: 180days
The best detector of acute kidney injury
The results of statistical analyses for the best predictor for upcoming AKI
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start14 Sep 2019
- Primary completion3 Sep 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMMED FAWZI ALI ABOSAMAK, Tanta University
- Investigators
- Mohammed Abosamak, Principal investigator, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554628
- Sponsor's protocol ID
- Security forces hospital
- Status last verified
- Mar 2021
- First submitted
- 3 Sep 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU
- ClinicalTrials.gov ID
- NCT04554628
- Acronym / sponsor ID
- Security forces hospital
- Conditions
- Acute Kidney Injury, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 18 Sep 2020 (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.
Early prediction of AKI can help to improve patients' outcome through early institution of the appropriate intervention, thus the current study hypothesizes that urine analysis for certain markers may provide an early knowledge about the possibility of oncoming kidney affection secondary to organ and tissue trauma affecting patients admitted to surgical ICU.
The current study tries to evaluate the value of urinary markers as early predictors of possible development of AKI in patients admitted to surgical ICU.
Detailed description
All patients will be clinically evaluated for demographic and clinical data. Severity of injury and number of surgical interventions will be evaluated using the simplified Therapeutic Intervention Scoring System (TISS-28) and the extent of impact of associated diseases on patients' physiological and body organs' functions will be evaluated using the Acute Physiology and Chronic Health Evaluation (APACHE II) and sequential organ failure assessment (SOFA) . Higher scores indicate more severe illness and for the TISS-28 score, each therapeutic intervention will be assigned 1 to 4 points, and the points will be summed daily to obtain the overall score and higher score indicates a higher number of therapeutic interventions.
Diagnosis of AKI Development of AKI within the first 48 hours after ICU admission and its staging will be defined according to the Acute Kidney Injury Network criteria. Each stage will be defined by the extent of change in serum creatinine level (∆SCr) as follows: Mild if Scr was increased by ≥0.3 mg/ml or ∆SCr was ≥1.5-2-fold from baseline, Moderate if ∆SCr was >2-3-fold from baseline and Severe if ∆SCr was increase by >3-fold from baseline .
Laboratory investigations Blood samples will be sent for estimation of serum creatinine (SCr) . Urine samples will be sent for spot creatinine , UNGAL, KIM1.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary human neutrophil gelatinase-associated lipocalin | Active comparator | Diagnostic Test: ELISA test in urineUrinary human neutrophil gelatinase-associated lipocalin (U-NGAL) measurement |
| Urinary human kidney injury molecule 1 (U-KIM1) | Active comparator | Diagnostic Test: ELISA test in urineUrinary human kidney injury molecule 1 (U-KIM1) measurement group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who were admitted to surgical ICU will be eligible for evaluation for inclusion and exclusion criteria.
Key exclusion criteria (6 listed)
- Patients with manifest kidney disease.
- Patients had renal surgery
- Patients maintained on renal replacement therapy
- Patients had diabetic nephropathy.
- Patients had liver disease, endocrinopathies.
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 |
|---|---|---|
| ELISA test in urineAlso: enzyme linked immunosorbent assay technologyenzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients | Diagnostic test | Urinary human kidney injury molecule 1 (U-KIM1), Urinary human neutrophil gelatinase-associated lipocalin |
Primary outcome
The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.
Time frame: 180 days
The ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.
2 secondary outcomes
The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity
Time frame: 180days
The best detector of acute kidney injury
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: Yes
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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. This study is not recruiting at the moment.
Mohammed Abosamak principal investigator
Security Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA test in urine in people with Acute Kidney Injury and Biomarkers, run by Tanta University at 1 site in Saudi Arabia.
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 6 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: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The ability of estimated urinary markers for prediction of patients susceptible to develop AKI. (time frame: 180 days). 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 10 Mar 2021.