Protocol to Assess the Severity of Acute Kidney Injury (AKI)

October 12, 2022 updated by: George Washington University
The principal objective is to safely determine if we can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict the course of AKI (recovery v. RRT v. death)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AKI is a very common disease in the intensive care unit. However, despite advances in supportive care, patients with AKI carry a high mortality rate (50% to 70%). The established AKI affects nearly 5 percent of hospitalized persons and as many as 15 percent of critically ill patients. Currently, there are no FDA approved therapeutic agents for the treatment of AKI.

Retrospective studies suggest that the early initiation of renal replacement therapy (RRT) improves outcome. Many clinicians tend to take a "wait and see" approach because they do not want to dialyze a patient who is destined to recover renal function without the need for RRT. Therefore, it is vitally important to know early in the course which patients with AKI are likely to progress to RRT.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 18 years and older
  • Increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater or equal to 150 to 200% from baseline or sustained oliguria(mean urine output of <0.5 cc/kg/hr for 6 hours within 48 hours)
  • Written informed consent
  • Patients who already have a indwelling bladder catheter

Exclusion Criteria:

  • Voluntary refusal or missing written consent of the patient or the designated legal representative
  • Patients with advanced Chronic Kidney Disease - as defined by a baseline GFR of < 30 ml/min as calculated by the MDRD equation
  • Patients with renal transplantation
  • Pregnancy
  • Patients with an allergy or sensitivity to loop diuretics

  • Patients with a clinical syndrome consistent with pre-renal AKI

    • Defined by fractional excretion of Na of < 1% AND no evidence of the urinary casts, or
    • Patients that are under-resuscitated as deemed by treating clinical team or
    • Patients who are actively bleeding

  • Patients with a clinical syndrome of post-renal AKI

    • Any radiological study that shows hydro-ureter, or
    • Clinical scenario wherein the obstruction is considered a likely possibility of the cause of AKI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Furosemide
One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.
Other Names:
  • Lasix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Volume
Time Frame: Time from furosemide administration to 6 hours after furosemide administration
Urine output measured in ml/hr for first 6 hours after furosemide administration
Time from furosemide administration to 6 hours after furosemide administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

  • Principal Investigator: Lakmir S Chawla, MD, George Washigton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (ESTIMATE)

May 7, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 010835

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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