Trial Outcomes & Findings for The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury (NCT NCT01275729)

NCT ID: NCT01275729

Last Updated: 2023-07-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: within 7 days of furosemide administration
• Results posted on: 2023-07-07

Participant Flow

Participant milestones

Measure	Lasix Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Overall Study STARTED	96
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Lasix Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Overall Study Death	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lasix n=92 Participants Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Age, Continuous	64.2 years STANDARD_DEVIATION 14.68 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Race/Ethnicity, Customized African American	42 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 participants n=5 Participants
Race/Ethnicity, Customized Native	1 participants n=5 Participants
Race/Ethnicity, Customized Other	8 participants n=5 Participants

PRIMARY outcome

Timeframe: within 7 days of furosemide administration

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

Outcome measures

Measure	Lasix n=92 Participants Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Progression to Stage 3 AKI	23 Participants

PRIMARY outcome

Timeframe: within 7 days of furosemide administration

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

Outcome measures

Measure	Lasix n=92 Participants Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Receipt of Renal Replacement Therapy (RRT)	10 Participants

PRIMARY outcome

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

Inpatient mortality

Outcome measures

Measure	Lasix n=92 Participants Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Death	16 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Lasix n=92 Participants Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Length of Intensive Care Unit (ICU) Stay	9.15 days Standard Error 1.45

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Lasix n=92 Participants Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Length of Hospital Stay	17.29 days Standard Error 2.4

Adverse Events

Lasix

Serious events: 0 serious events

Other events: 19 other events

Deaths: 16 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lasix n=92 participants at risk Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics Furosemide: dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
Cardiac disorders Hypotension- defined requiring intervention by means of fluid administration or vasopressor support	9.8% 9/92 • During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Metabolism and nutrition disorders Hypokalemia	5.4% 5/92 • During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Metabolism and nutrition disorders Hypomagnesemia	5.4% 5/92 • During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first

Additional Information

Dr. Jay L Koyner

University of Chicago

Phone: 773-702-4842

Email: jkoyner@uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place