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

Critical Illness Clinical Trial

— PRAIOC-RISKS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178435
• Other study ID #: KA-13050
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: February 2019
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AKI	We will compare the incidence rate between the interventional and the observational arm	during 7 days of ICU admission
Secondary	30 day mortality	all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI	30 days
Secondary	Time to recovery after development of AKI	Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria	30 days
Secondary	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
Secondary	Duration of dialysis dependency	time patient remains dialysis-dependant after severe AKI.	30 days