Acute Kidney InjuryPRAIOC-RISKSNCT03178435
Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score
A study testing Measures to prevent AKI among critically ill patients in people with Acute Kidney Injury and Critical Illness, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
An interventional controlled trial to test the feasibility of applying risk score based prevention for critically ill patient at high risk to develop acute kidney injury (AKI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Critical Illness
- What is being tested?
- Measures to prevent AKI among critically ill patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Sep 2018
- 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 adult patients (≥18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition
Who cannot join
- Patients who have already developed AKI at the time of intensive care unit ICU admission.
- Patients with insufficient medical records to obtain previous medical history
- Patients who lack mental capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial
An interventional controlled trial to test the feasibility of applying risk score based prevention for critically ill patient at high risk to develop acute kidney injury (AKI)
Read the detailed description
Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.
There is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.
The focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.
The concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.
Another evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.
KDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions
Hypothesis:
We will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment
- Conditions
- Acute Kidney Injury, Critical Illness
- Being tested
- Measures to prevent AKI among critically ill patients
- Keywords
- risk score, Acute kidney injury, critical care
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures to prevent AKI among critically ill patientsOther
- Meticulous optimization of the fluid balance
- Avoidance of nephrotoxic medications where possible
- Optimisation of the hemodynamic status
- Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia
- Optimization of the underlying medical condition
- Seek expert renal advise when necessary
| Study group | Role | What they receive |
|---|---|---|
| Observational | No intervention | patients will be recruited to this arm to observe prospectively the incidence of AKI among critically ill patients.patients will receive the standard care.No other intervention will be delivered |
| Interventional | Active comparator | Patients in this arm will be subject to AKI risk score. This risk score was recently developed and validated in Mayo clinic the intervention will be Measures to prevent AKI among critically ill patients Receives: Other: Measures to prevent AKI among critically ill patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI
We will compare the incidence rate between the interventional and the observational arm
Measured: during 7 days of ICU admission
Secondary outcomes (4)
30 day mortality
all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI
Measured: 30 days
Time to recovery after development of AKI
Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria
Measured: 30 days
Deterioration of AKI stage
Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3
Measured: 30 days
Duration of dialysis dependency
time patient remains dialysis-dependant after severe AKI.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Sep 2017
- Primary completion1 Apr 2018
- Study completion1 Sep 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional cluster randomised trial -pilot /feasibility study
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178435
- Sponsor's protocol ID
- KA-13050
- Acronym
- PRAIOC-RISKS
- Status last verified
- Feb 2019
- First submitted
- 4 Jun 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03178435
- Acronym / sponsor ID
- PRAIOC-RISKS / KA-13050
- Conditions
- Acute Kidney Injury, Critical Illness
- Keywords
- risk score, Acute kidney injury, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 7 Jun 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.
An interventional controlled trial to test the feasibility of applying risk score based prevention for critically ill patient at high risk to develop acute kidney injury (AKI)
Detailed description
Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.
There is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.
The focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.
The concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.
Another evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.
KDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions
Hypothesis:
We will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- interventional cluster randomised trial -pilot /feasibility study
| Arm | Type | Receives |
|---|---|---|
| Observational | No intervention | –patients will be recruited to this arm to observe prospectively the incidence of AKI among critically ill patients.patients will receive the standard care.No other intervention will be delivered |
| Interventional | Active comparator | Other: Measures to prevent AKI among critically ill patientsPatients in this arm will be subject to AKI risk score. This risk score was recently developed and validated in Mayo clinic the intervention will be Measures to prevent AKI among critically ill patients |
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 adult patients (≥18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition
Key exclusion criteria (3 listed)
- Patients who have already developed AKI at the time of intensive care unit ICU admission.
- Patients with insufficient medical records to obtain previous medical history
- Patients who lack mental capacity
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 |
|---|---|---|
| Measures to prevent AKI among critically ill patients1. Meticulous optimization of the fluid balance 2. Avoidance of nephrotoxic medications where possible 3. Optimisation of the hemodynamic status 4. Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia 5. Optimization of the underlying medical condition 6. Seek expert renal advise when necessary | Other | Interventional |
Primary outcome
Incidence of AKI
Time frame: during 7 days of ICU admission
We will compare the incidence rate between the interventional and the observational arm
4 secondary outcomes
30 day mortality
Time frame: 30 days
Time to recovery after development of AKI
Time frame: 30 days
Deterioration of AKI stage
Time frame: 30 days
Duration of dialysis dependency
Time frame: 30 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 26 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measures to prevent AKI among critically ill patients in people with Acute Kidney Injury and Critical Illness, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 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 26 Feb 2019. 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 Egypt. 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?
Incidence of AKI (time frame: during 7 days of ICU admission). 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 26 Feb 2019.