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

NCT ID: NCT03178435

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-09-01

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

Conditions

Acute Kidney Injury; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Measures to prevent AKI among critically ill patients

Intervention Type: OTHER

1. Meticulous optimization of the fluid balance

2. Avoidance of nephrotoxic medications where possible

3. Optimisation of the hemodynamic status

4. Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia

5. Optimization of the underlying medical condition

6. Seek expert renal advise when necessary

Interventions

Measures to prevent AKI among critically ill patients

1. Meticulous optimization of the fluid balance

2. Avoidance of nephrotoxic medications where possible

3. Optimisation of the hemodynamic status

4. Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia

5. Optimization of the underlying medical condition

6. Seek expert renal advise when necessary

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tarek Samy Abdelaziz

Senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

KA-13050

Identifier Type: -

Identifier Source: org_study_id