The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury

NCT01275729 | Completed Results

• 1 other identifier: 10-503-B
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. The investigators are attempting to determine if these biomarkers can forecast the course of AKI (need for dialysis, death and renal recovery). The investigators seek to determine how well physicians caring for those with AKI can predict the clinical course compared to these novel biomarkers of AKI and if there is an association between clinical course and 3 year patient outcomes.

Conditions

Acute Kidney Failure

Keywords

Renal Replacement Therapy; Diuretics; Biomarkers; Renal Insufficiency; Furosemide; Therapeutic Uses; Physiological Effects of Drugs; Biological Markers

Outcome Measures

Primary Outcomes (3)

• Progression to Stage 3 AKI

  The number of patients who progressed to Stage 3 during the time of observation

  within 7 days of furosemide administration

• Receipt of Renal Replacement Therapy (RRT)

  The number of patients who received renal replacement therapy (Dialysis)

  within 7 days of furosemide administration

• Death

  Inpatient mortality

  During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first

Secondary Outcomes (2)

• Length of Intensive Care Unit (ICU) Stay

  During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first

• Length of Hospital Stay

  During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first

Study Arms (1)

Lasix

EXPERIMENTAL

Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics

Drug: Furosemide

Interventions

Furosemide DRUG

dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive

Also known as: Laisx

Lasix

Eligibility Criteria

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

You may qualify if:

• yrs or older
• increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP \< 0.5 cc/kg/hr for 6 hours with the last 48hours)
• written informed consent
• patients with an indwelling bladder catheter

You may not qualify if:

• Voluntary refusal
• Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) \< 30 ml/min (MDRD)
• history of renal transplant
• Pregnant patients
• Allergy / Sensitivity to Loop diuretics (furosemide)
• Pre-renal AKI
• defined by a Fractional Excretion of Sodium (FENa) of \< 1% and no urinary casts
• under-resuscitated as per the treating clinical team
• active bleed
• Post renal AKI
• evidence of hydro-ureter
• clinical scenario wherein obstruction is considered a likely possibility

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (4)

University of California-San Francisco

San Francisco, California, 94143, United States

Location

George Washington University

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

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Jay L Koyner
• Organization: University of Chicago

jkoyner@uchicago.edu

773-702-4842

Study Officials

• Jay L Koyner, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-06

Locations

US (4)