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

NCT03178435 | Completed DMC

• 1 other identifier: KA-13050
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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)

Conditions

Acute Kidney Injury; Critical Illness

Keywords

risk score; Acute kidney injury; critical care

Outcome Measures

Primary Outcomes (1)

• Incidence of AKI

  We will compare the incidence rate between the interventional and the observational arm

  during 7 days of ICU admission

Secondary Outcomes (4)

• 30 day mortality

  30 days

• Time to recovery after development of AKI

  30 days

• Deterioration of AKI stage

  30 days

• Duration of dialysis dependency

  30 days

Study Arms (2)

Observational

NO INTERVENTION

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

Interventional

ACTIVE COMPARATOR

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

Interventions

Measures to prevent AKI among critically ill patients 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

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Model Details: interventional cluster randomised trial -pilot /feasibility study

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 7, 2017
• Study Start: September 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)