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

Not Applicable

Completed

• Conditions: Acute Kidney Injury; Critical Illness
• Interventions: Other: Measures to prevent AKI among critically ill patients

• Registration Number: NCT03178435
• Lead Sponsor: Kasr El Aini Hospital

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

Study Timeline

• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Study Start: 2017-09-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-09-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Measures to prevent AKI among critically ill patients	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

Primary Outcome Measures

Name	Time	Method
Incidence of AKI	during 7 days of ICU admission	We will compare the incidence rate between the interventional and the observational arm

Secondary Outcome Measures

Name	Time	Method
30 day mortality	30 days	all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI
Time to recovery after development of AKI	30 days	Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria
Deterioration of AKI stage	30 days	Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3
Duration of dialysis dependency	30 days	time patient remains dialysis-dependant after severe AKI.

Trial Locations

Locations (1)

Cairo university hospitals; 🇪🇬 Cairo, Egypt