Skip to main content
OpenTrials
Completed

NCT Number: NCT00673244

Protocol to Assess the Severity of Acute Kidney Injury

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Kidney Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Acronym: AKI

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 7, 2008
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.