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Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score

Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03178435
Acronym
PRAIOC-RISKS
Enrollment
198
Registered
2017-06-07
Start date
2017-09-01
Completion date
2018-09-01
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Critical Illness

Keywords

risk score, Acute kidney injury, critical care

Brief 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)

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

Interventions

OTHERMeasures to prevent AKI among critically ill patients

1. 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

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

interventional cluster randomised trial -pilot /feasibility study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Patients who have already developed AKI at the time of intensive care unit ICU admission. 2. Patients with insufficient medical records to obtain previous medical history 3. Patients who lack mental capacity

Design outcomes

Primary

MeasureTime frameDescription
Incidence of AKIduring 7 days of ICU admissionWe will compare the incidence rate between the interventional and the observational arm

Secondary

MeasureTime frameDescription
30 day mortality30 daysall cause mortality during 30 days of ICU admission or within 30 days of developement of AKI
Time to recovery after development of AKI30 daysTime interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria
Deterioration of AKI stage30 daysTransition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3
Duration of dialysis dependency30 daystime patient remains dialysis-dependant after severe AKI.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026