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Clinical Trials/NCT03178435
NCT03178435
Completed
Not Applicable

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

Kasr El Aini Hospital1 site in 1 country198 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Kasr El Aini Hospital
Enrollment
198
Locations
1
Primary Endpoint
Incidence of AKI
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
September 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kasr El Aini Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tarek Samy Abdelaziz

Senior lecturer

Kasr El Aini Hospital

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

Incidence of AKI

Time Frame: during 7 days of ICU admission

We will compare the incidence rate between the interventional and the observational arm

Secondary Outcomes

  • Time to recovery after development of AKI(30 days)
  • 30 day mortality(30 days)
  • Deterioration of AKI stage(30 days)
  • Duration of dialysis dependency(30 days)

Study Sites (1)

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