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Completed

NCT Number: NCT01275729

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

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.

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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

University of California-San Francisco, San Francisco, California, United States

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About this study

AKI is a very common disease in the setting of critical illness and carries an extremely high morbidity and mortality rate (over 50%). Currently there are no FDA approved therapeutic agents for the treatment of AKI. There is limited prospective evidence to guide nephrologists in terms of which patients will progress to more severe AKI in the setting of early AKI. Similarly, there is no evidence to guide nephrologists in terms of which patients will completely recover their renal function after AKI. Thus we need to know very early in the course of AKI which patients will progress and go on to require renal replacement therapy (RRT). Additionally we will investigating the long term patient outcomes, 2-3 years after the index AKI admission.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Laisx

Primary outcomes

  1. Progression to Stage 3 AKI

    Time frame: within 7 days of furosemide administration

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

  2. Receipt of Renal Replacement Therapy (RRT)

    Time frame: within 7 days of furosemide administration

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

  3. Death

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

    Inpatient mortality

Secondary outcomes

  1. Length of Intensive Care Unit (ICU) Stay

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

    duration if ICU stay for all patients

  2. Length of Hospital Stay

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

    duration of the total hospital Stay for all patients

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2011
Registry last updated
Jul 7, 2023

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.

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