Skip to main content
OpenTrials
Completed

NCT Number: NCT03178435

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

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)

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measures to prevent AKI among critically ill patients

Other
  • 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

Primary outcomes

  1. 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

  1. 30 day mortality

    Time frame: 30 days

    all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI

  2. Time to recovery after development of AKI

    Time frame: 30 days

    Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria

  3. Deterioration of AKI stage

    Time frame: 30 days

    Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3

  4. Duration of dialysis dependency

    Time frame: 30 days

    time patient remains dialysis-dependant after severe AKI.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Acronym: PRAIOC-RISKS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.