Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score (PRAIOC-RISKS)

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)

Study Overview

• Status: Completed
• Conditions: Critical Illness; Acute Kidney Injury
• Intervention / Treatment: Other: Measures to prevent AKI among critically ill patients

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 Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational; 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
Active Comparator: Interventional; 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	Other: Measures to prevent AKI among critically ill patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AKI	We will compare the incidence rate between the interventional and the observational arm	during 7 days of ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day mortality	all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI	30 days
Time to recovery after development of AKI	Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria	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	30 days
Duration of dialysis dependency	time patient remains dialysis-dependant after severe AKI.	30 days

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: critical care; Acute kidney injury; risk score
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Wounds and Injuries; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: KA-13050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No