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

Primary Purpose

Acute Kidney Injury, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Measures to prevent AKI among critically ill patients
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring risk score, Acute kidney injury, critical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Observational

Interventional

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of AKI
We will compare the incidence rate between the interventional and the observational arm

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2017
Last Updated
February 25, 2019
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03178435
Brief Title
Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Critical Illness
Keywords
risk score, Acute kidney injury, critical care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
interventional cluster randomised trial -pilot /feasibility study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observational
Arm Type
No Intervention
Arm Description
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
Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Measures to prevent AKI among critically ill patients
Intervention Description
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 Outcome Measure Information:
Title
Incidence of AKI
Description
We will compare the incidence rate between the interventional and the observational arm
Time Frame
during 7 days of ICU admission
Secondary Outcome Measure Information:
Title
30 day mortality
Description
all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI
Time Frame
30 days
Title
Time to recovery after development of AKI
Description
Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria
Time Frame
30 days
Title
Deterioration of AKI stage
Description
Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3
Time Frame
30 days
Title
Duration of dialysis dependency
Description
time patient remains dialysis-dependant after severe AKI.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cairo university hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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