Acute Kidney InjuryNCT03338127
Outcomes of Acute Kidney Injury in Critically Ill Patients
An observational study of Acute Kidney Injury, run by Alaa H Fahmy.
Trial summary
this study to evaluate the frequency of acute kidney injury in critically ill patients in intensive care units. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- renal function test
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 30 Jun 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient willl be recruited from critical care units in Luxor international hospital
Who may be able to join
- All patient with acute kidney injury in critical care units in Luxor international hospital
Who cannot join
- Patients on chronic dialysis
- Previous acute kidney injury
- Nephrectomy
- Organ transplant
- Chronic kidney disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of Acute Kidney Injury in Critically Ill Patients in Luxor International Hospital
this study to evaluate the frequency of acute kidney injury in critically ill patients in intensive care units.
Read the detailed description
Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (ICU), making it among the most common organ dysfunctions among the critically ill . Depending on severity, Acute kidney injury (AKI) contributes to short-perimortality rates between 40% and 70% , and survivors are at increased risk for chronic kidney disease (CKD) and late death.
The diagnosis of Acute kidney injury (AKI) is only considered after achieving an adequate status of hydration and after excluding urinary obstruction; Acute kidney injury (AKI) is defined by the sudden decrease (in 48 h) of renal function, defined by an increase in absolute serum creatinine of at least (0.3 mg/dL) or by a percentage increase in serum creatinine ≥50% (1.5× baseline value), or by a decrease in the urinary output (documented oliguria <0.5 mL/kg/h for more than 6hours).
The purpose of this study was to benchmark the outcomes of acute kidney injury in a critically ill surgical patients.We hypothesized that renal dysfunction in this population is common and is associated with a significantly higher burden of morbidity, mortality, and resource utilization
- Conditions
- Acute Kidney Injury
- Being tested
- renal function test
- 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.
renal function testDiagnostic test
2 ml blood sample to be investigated for renal function test
| Study group | Role | What they receive |
|---|---|---|
| Participants | all patients recruited in the trial will be investigated for renal function test Receives: Diagnostic Test: renal function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury in critically ill patients
To evaluate the frequency of acute kidney injury in critically ill patients admitted in intensive care units.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
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.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa H Fahmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa H Fahmy, Assiut University
- Investigators
- Ahmed M Aly, professor, Study director, professor of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338127
- Sponsor's protocol ID
- AssiutU AHFahmy
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Acute Kidney Injury in Critically Ill Patients in Luxor International Hospital
- ClinicalTrials.gov ID
- NCT03338127
- Acronym / sponsor ID
- AssiutU AHFahmy
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alaa H FahmyUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 9 Nov 2017 (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.
this study to evaluate the frequency of acute kidney injury in critically ill patients in intensive care units.
Detailed description
Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (ICU), making it among the most common organ dysfunctions among the critically ill . Depending on severity, Acute kidney injury (AKI) contributes to short-perimortality rates between 40% and 70% , and survivors are at increased risk for chronic kidney disease (CKD) and late death.
The diagnosis of Acute kidney injury (AKI) is only considered after achieving an adequate status of hydration and after excluding urinary obstruction; Acute kidney injury (AKI) is defined by the sudden decrease (in 48 h) of renal function, defined by an increase in absolute serum creatinine of at least (0.3 mg/dL) or by a percentage increase in serum creatinine ≥50% (1.5× baseline value), or by a decrease in the urinary output (documented oliguria <0.5 mL/kg/h for more than 6hours).
The purpose of this study was to benchmark the outcomes of acute kidney injury in a critically ill surgical patients.We hypothesized that renal dysfunction in this population is common and is associated with a significantly higher burden of morbidity, mortality, and resource utilization
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: renal function testall patients recruited in the trial will be investigated for renal function test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient willl be recruited from critical care units in Luxor international hospital
Key inclusion criteria (1 listed)
- All patient with acute kidney injury in critical care units in Luxor international hospital
Key exclusion criteria (5 listed)
- Patients on chronic dialysis
- Previous acute kidney injury
- Nephrectomy
- Organ transplant
- Chronic kidney 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 |
|---|---|---|
| renal function test2 ml blood sample to be investigated for renal function test | Diagnostic test | Participants |
Primary outcome
Acute kidney injury in critically ill patients
Time frame: 10 days
To evaluate the frequency of acute kidney injury in critically ill patients admitted in intensive care units.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: Undecided
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)
Not yet recruiting
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.
Ahmed M Aly, professor study director
professor of internal medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Alaa H Fahmy.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa H Fahmy (00201118929161, alaaheshmat90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury in critically ill patients (time frame: 10 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 13 Nov 2017.