Trial Outcomes & Findings for Protocol to Assess the Severity of Acute Kidney Injury (NCT NCT00673244)
NCT ID: NCT00673244
Last Updated: 2022-10-18
Results Overview
Urine output measured in ml/hr for first 6 hours after furosemide administration
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
Time from furosemide administration to 6 hours after furosemide administration
Results posted on
2022-10-18
Participant Flow
Participant milestones
| Measure |
Did Not Progress to AKIN Stage III
Did not meet the following criteria within 14 days of furosemide stress test (FST): Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours
|
Progressed to AKIN Stage III
Meet the following criteria within 14 days of Furosemide stress test (FST): need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
25
|
|
Overall Study
COMPLETED
|
52
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protocol to Assess the Severity of Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
Did Not Progress to AKIN Stage III
n=52 Participants
Subject did not require RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST.
|
Progressed to AKIN Stage III
n=25 Participants
Subject required RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of FST.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
68.2 years
STANDARD_DEVIATION 1.9 • n=107 Participants
|
65.3 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
29 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Chronic kidney disease
|
17 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Hypertension
|
41 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Congestive heart failure
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Diabetes
|
22 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
NSAIDS
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Aminoglycosides
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Amphotericin
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Contrast
|
15 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Post-cardiac surgery
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sepsis
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Baseline eGFR
|
60.6 ml/minute/1.73m2
STANDARD_DEVIATION 8.8 • n=99 Participants
|
73.3 ml/minute/1.73m2
STANDARD_DEVIATION 4.2 • n=107 Participants
|
68.6 ml/minute/1.73m2
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
Baseline UFR
|
95.7 ml/hr
STANDARD_DEVIATION 16.3 • n=99 Participants
|
29.7 ml/hr
STANDARD_DEVIATION 4.2 • n=107 Participants
|
74.6 ml/hr
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Furosemide-naïve
|
23 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Urinary Sediment Cast Scoring Index for Acute Kidney Injury
|
2.1 Scores on a scale
STANDARD_DEVIATION 0.16 • n=99 Participants
|
2.7 Scores on a scale
STANDARD_DEVIATION 0.23 • n=107 Participants
|
2.3 Scores on a scale
STANDARD_DEVIATION 0.13 • n=206 Participants
|
|
FeNa above 1%
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Cardiovascular Sequential Organ Failure Assessment
|
1.05 Scores on a scale
STANDARD_DEVIATION 0.2 • n=99 Participants
|
1.5 Scores on a scale
STANDARD_DEVIATION 0.4 • n=107 Participants
|
1.16 Scores on a scale
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
APACHE II score
|
16.5 Scores of a scale
STANDARD_DEVIATION 1.2 • n=99 Participants
|
21.6 Scores of a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
17.8 Scores of a scale
STANDARD_DEVIATION 1.11 • n=206 Participants
|
|
AKIN stage at enrollment
AKIN I
|
34 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
AKIN stage at enrollment
AKIN II
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from furosemide administration to 6 hours after furosemide administrationUrine output measured in ml/hr for first 6 hours after furosemide administration
Outcome measures
| Measure |
Progressed to AKIN Stage III
n=25 Participants
Need for RRT, increase in serum creatinine of 300% over baseline, urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test.
|
Did Not Progress to AKIN Stage-III
n=52 Participants
Did not need RRT, have increase in serum creatinine of 300% over baseline, or have urine output of 0.3 cc/kg/hour × 24 hours within 14 days of furosemide stress test.
|
|---|---|---|
|
Urine Volume
Urine Volume - Hour 1
|
89 ml
Standard Error 33
|
329 ml
Standard Error 46
|
|
Urine Volume
Urine Volume - Hour 2
|
96 ml
Standard Error 46.6
|
392 ml
Standard Error 42.2
|
|
Urine Volume
Urine Volume - Hour 3
|
109 ml
Standard Error 35.4
|
311 ml
Standard Error 31.7
|
|
Urine Volume
Urine Volume - Hour 4
|
88 ml
Standard Error 23.4
|
265 ml
Standard Error 31.1
|
|
Urine Volume
Urine Volume - Hour 5
|
83 ml
Standard Error 23.7
|
219 ml
Standard Error 22.8
|
|
Urine Volume
Urine Volume - Hour 6
|
75 ml
Standard Error 17.4
|
194 ml
Standard Error 22.3
|
Adverse Events
Progressed to AKIN III
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Did Not Progress to AKIN III
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lakhmir S. Chawla
Department of Anesthesiology and Critical Care Medicine, George Washington University
Phone: 202-994-7903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place