Trial Outcomes & Findings for Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study) (NCT NCT00577135)
NCT ID: NCT00577135
Last Updated: 2018-03-06
Results Overview
Global Visual Analog Scale Scale Range 0-7200; higher score is better
COMPLETED
PHASE3
308 participants
Measured at 72 hours
2018-03-06
Participant Flow
Participant milestones
| Measure |
Q12 Hours Bolus & Low Intensification
Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
|
Q12 Hours Bolus & High Intensification
High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
|
Continuous Infusion & Low Intensification
Low intensification (1 x oral dose) IV furosemide by continuous infusion
|
Continuous Infusion & High Intensification
High intensification (2.5 x oral dose) IV furosemide by continuous infusion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
82
|
77
|
75
|
|
Overall Study
COMPLETED
|
74
|
82
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
Baseline characteristics by cohort
| Measure |
Q12 Hours Bolus & Low Intensification
n=74 Participants
|
Q12 Hours Bolus & High Intensification
n=82 Participants
|
Continuous Infusion & Low Intensification
n=77 Participants
|
Continuous Infusion & High Intensification
n=75 Participants
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Global Visual Analog Scale Scale Range 0-7200; higher score is better
Outcome measures
| Measure |
Low Intensification
n=148 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=154 Participants
|
Continuous Infusion
n=149 Participants
|
|---|---|---|---|---|
|
Patient Well Being, as Determined by a Visual Analog Scale
|
4170.8 units on a scale
Standard Deviation 1436.3
|
4429.6 units on a scale
Standard Deviation 1401.4
|
4236 units on a scale
Standard Deviation 1440.4
|
4372.7 units on a scale
Standard Deviation 1404.4
|
PRIMARY outcome
Timeframe: Measured at baseline and 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=154 Participants
|
Q 12 Hour Bolus
n=155 Participants
|
Continuous Infusion
n=146 Participants
|
|---|---|---|---|---|
|
Change in Serum Creatinine
|
0.04 mg/dL
Standard Deviation 0.29
|
0.08 mg/dL
Standard Deviation 0.31
|
0.05 mg/dL
Standard Deviation 0.30
|
0.07 mg/dL
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: baseline and 96 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=141 Participants
|
High Intensification
n=152 Participants
|
Q 12 Hour Bolus
n=151 Participants
|
Continuous Infusion
n=142 Participants
|
|---|---|---|---|---|
|
Change in Weight
|
-7.4 lbs
Standard Deviation 10.1
|
-9.6 lbs
Standard Deviation 7.9
|
-8.0 lbs
Standard Deviation 7.8
|
-9.1 lbs
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Measured at 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=143 Participants
|
High Intensification
n=154 Participants
|
Q 12 Hour Bolus
n=153 Participants
|
Continuous Infusion
n=144 Participants
|
|---|---|---|---|---|
|
Proportion of Patients Free of Congestion
|
11.2 percentage of participants
|
18.2 percentage of participants
|
14.4 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: Measured at 24 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Global Visual Analog Scale Scale Range 0-2400; higher score is better
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=153 Participants
|
Continuous Infusion
n=149 Participants
|
|---|---|---|---|---|
|
Dyspnea, as Determined by Visual Analog Scales
|
1426.0 units on a scale
Standard Deviation 504.5
|
1398.2 units on a scale
Standard Deviation 502.7
|
1370.8 units on a scale
Standard Deviation 486.0
|
1453.8 units on a scale
Standard Deviation 518.0
|
SECONDARY outcome
Timeframe: baseline and 24 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=153 Participants
|
Q 12 Hour Bolus
n=154 Participants
|
Continuous Infusion
n=146 Participants
|
|---|---|---|---|---|
|
Change in Serum Creatinine
|
-0.01 mg/dL
Standard Deviation 0.16
|
0.02 mg/dL
Standard Deviation 0.19
|
0.00 mg/dL
Standard Deviation 0.18
|
0.01 mg/dL
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: baseline and 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=121 Participants
|
High Intensification
n=126 Participants
|
Q 12 Hour Bolus
n=125 Participants
|
Continuous Infusion
n=122 Participants
|
|---|---|---|---|---|
|
Change in Cystatin C
|
0.12 mg/L
Standard Deviation 0.35
|
0.17 mg/L
Standard Deviation 0.31
|
0.11 mg/L
Standard Deviation 0.30
|
0.17 mg/L
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: baseline and 48 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=154 Participants
|
Q 12 Hour Bolus
n=155 Participants
|
Continuous Infusion
n=146 Participants
|
|---|---|---|---|---|
|
Change in Serum Creatinine
|
0.01 mg/dL
Standard Deviation 0.23
|
0.06 mg/dL
Standard Deviation 0.25
|
0.02 mg/dL
Standard Deviation 0.23
|
0.05 mg/dL
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: baseline and 96 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=154 Participants
|
Q 12 Hour Bolus
n=155 Participants
|
Continuous Infusion
n=146 Participants
|
|---|---|---|---|---|
|
Change in Serum Creatinine
|
0.05 mg/dL
Standard Deviation 0.33
|
0.07 mg/dL
Standard Deviation 0.31
|
0.06 mg/dL
Standard Deviation 0.32
|
0.05 mg/dL
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: baseline and day 7Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=154 Participants
|
Q 12 Hour Bolus
n=155 Participants
|
Continuous Infusion
n=146 Participants
|
|---|---|---|---|---|
|
Change in Serum Creatinine
|
0.07 mg/dL
Standard Deviation 0.33
|
0.08 mg/dL
Standard Deviation 0.40
|
0.10 mg/dL
Standard Deviation 0.40
|
0.04 mg/dL
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: baseline and day 60Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=114 Participants
|
High Intensification
n=119 Participants
|
Q 12 Hour Bolus
n=117 Participants
|
Continuous Infusion
n=116 Participants
|
|---|---|---|---|---|
|
Change in Serum Creatinine
|
0.09 mg/dL
Standard Deviation 0.43
|
0.07 mg/dL
Standard Deviation 0.43
|
0.09 mg/dL
Standard Deviation 0.41
|
0.07 mg/dL
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Measured at 24 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Global Visual Analog Scale Scale Range 0-2400; higher score is better
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=153 Participants
|
Continuous Infusion
n=149 Participants
|
|---|---|---|---|---|
|
Patient Well Being, as Determined by a Visual Analog Scale
|
1288.6 units on a scale
Standard Deviation 455.9
|
1294.8 units on a scale
Standard Deviation 478.4
|
1280.8 units on a scale
Standard Deviation 469.7
|
1303.0 units on a scale
Standard Deviation 465.1
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Global Visual Analog Scale Scale Range 0-4800; higher score is better
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=153 Participants
|
Continuous Infusion
n=149 Participants
|
|---|---|---|---|---|
|
Patient Well Being, as Determined by a Visual Analog Scale
|
2706.5 units on a scale
Standard Deviation 931.5
|
2805.2 units on a scale
Standard Deviation 939.8
|
2722.6 units on a scale
Standard Deviation 940.0
|
2792.6 units on a scale
Standard Deviation 932.7
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=153 Participants
|
Continuous Infusion
n=149 Participants
|
|---|---|---|---|---|
|
Dyspnea VAS
|
2924.9 units on a scale
Standard Deviation 1012.8
|
2981.3 units on a scale
Standard Deviation 992.9
|
2876.6 units on a scale
Standard Deviation 960.1
|
3033.1 units on a scale
Standard Deviation 1039.3
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better
Outcome measures
| Measure |
Low Intensification
n=148 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=154 Participants
|
Continuous Infusion
n=149 Participants
|
|---|---|---|---|---|
|
Dyspnea VAS
|
4477.9 units on a scale
Standard Deviation 1549.7
|
4668.3 units on a scale
Standard Deviation 1496.0
|
4455.6 units on a scale
Standard Deviation 1468.4
|
4699.1 units on a scale
Standard Deviation 1572.7
|
SECONDARY outcome
Timeframe: baseline and day 7Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=131 Participants
|
High Intensification
n=137 Participants
|
Q 12 Hour Bolus
n=137 Participants
|
Continuous Infusion
n=131 Participants
|
|---|---|---|---|---|
|
Change in Cystatin C
|
0.16 mg/L
Standard Deviation 0.48
|
0.21 mg/L
Standard Deviation 0.42
|
0.21 mg/L
Standard Deviation 0.43
|
0.16 mg/L
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: baseline and day 60Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=91 Participants
|
High Intensification
n=99 Participants
|
Q 12 Hour Bolus
n=92 Participants
|
Continuous Infusion
n=98 Participants
|
|---|---|---|---|---|
|
Change in Cystatin C
|
0.18 mg/L
Standard Deviation 0.47
|
0.18 mg/L
Standard Deviation 0.46
|
0.20 mg/L
Standard Deviation 0.51
|
0.16 mg/L
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline and 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=120 Participants
|
High Intensification
n=126 Participants
|
Q 12 Hour Bolus
n=125 Participants
|
Continuous Infusion
n=121 Participants
|
|---|---|---|---|---|
|
Change in Uric Acid
|
0.11 mg/dL
Standard Deviation 1.01
|
0.61 mg/dL
Standard Deviation 1.15
|
0.30 mg/dL
Standard Deviation 1.02
|
0.44 mg/dL
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: baseline and day 7Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=130 Participants
|
High Intensification
n=137 Participants
|
Q 12 Hour Bolus
n=137 Participants
|
Continuous Infusion
n=130 Participants
|
|---|---|---|---|---|
|
Change in Uric Acid
|
0.07 mg/dL
Standard Deviation 1.69
|
0.42 mg/dL
Standard Deviation 1.75
|
0.40 mg/dL
Standard Deviation 1.47
|
0.09 mg/dL
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: baseline and Day 60Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=93 Participants
|
High Intensification
n=98 Participants
|
Q 12 Hour Bolus
n=92 Participants
|
Continuous Infusion
n=99 Participants
|
|---|---|---|---|---|
|
Change in Uric Acid
|
-0.13 mg/dL
Standard Deviation 2.33
|
-0.67 mg/dL
Standard Deviation 2.24
|
-0.09 mg/dL
Standard Deviation 2.28
|
-0.71 mg/dL
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: baseline and 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Change in NTproBNP
Outcome measures
| Measure |
Low Intensification
n=121 Participants
|
High Intensification
n=124 Participants
|
Q 12 Hour Bolus
n=124 Participants
|
Continuous Infusion
n=121 Participants
|
|---|---|---|---|---|
|
Change in B-type Natriuretic Peptide
|
-1193.8 pg/mL
Standard Deviation 4094.1
|
-1881.6 pg/mL
Standard Deviation 4105.4
|
-1316.2 pg/mL
Standard Deviation 4364.3
|
-1773.2 pg/mL
Standard Deviation 3827.5
|
SECONDARY outcome
Timeframe: baseline and Day 7Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=131 Participants
|
High Intensification
n=135 Participants
|
Q 12 Hour Bolus
n=136 Participants
|
Continuous Infusion
n=130 Participants
|
|---|---|---|---|---|
|
Change in NTproBNP
|
-1037.2 pg/mL
Standard Deviation 5211.8
|
-1629.7 pg/mL
Standard Deviation 4524.6
|
-1133.3 pg/mL
Standard Deviation 4883.4
|
-1552.0 pg/mL
Standard Deviation 4875.8
|
SECONDARY outcome
Timeframe: baseline and Day 60Population: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=91 Participants
|
High Intensification
n=98 Participants
|
Q 12 Hour Bolus
n=91 Participants
|
Continuous Infusion
n=98 Participants
|
|---|---|---|---|---|
|
Change in NTproBNP
|
-1445.6 pg/mL
Standard Deviation 5805.3
|
-1038.5 pg/mL
Standard Deviation 6364.3
|
-1449.3 pg/mL
Standard Deviation 5010.1
|
-1035.1 pg/mL
Standard Deviation 6962.9
|
SECONDARY outcome
Timeframe: Within 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=154 Participants
|
Q 12 Hour Bolus
n=155 Participants
|
Continuous Infusion
n=146 Participants
|
|---|---|---|---|---|
|
Presence of Cardiorenal Syndrome
|
13.6 percentage of participants
|
22.7 percentage of participants
|
17.4 percentage of participants
|
19.2 percentage of participants
|
SECONDARY outcome
Timeframe: Within 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization
Outcome measures
| Measure |
Low Intensification
n=147 Participants
|
High Intensification
n=155 Participants
|
Q 12 Hour Bolus
n=155 Participants
|
Continuous Infusion
n=147 Participants
|
|---|---|---|---|---|
|
Treatment Failure
|
36.7 percentage of participants
|
40.0 percentage of participants
|
38.1 percentage of participants
|
38.8 percentage of participants
|
SECONDARY outcome
Timeframe: Through 24 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=141 Participants
|
High Intensification
n=149 Participants
|
Q 12 Hour Bolus
n=150 Participants
|
Continuous Infusion
n=140 Participants
|
|---|---|---|---|---|
|
Net Fluid Loss
|
1209.7 mL
Standard Deviation 1309.3
|
2149.6 mL
Standard Deviation 1681.7
|
1595.7 mL
Standard Deviation 1476.7
|
1796.4 mL
Standard Deviation 1685.1
|
SECONDARY outcome
Timeframe: Through 48 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=139 Participants
|
High Intensification
n=145 Participants
|
Q 12 Hour Bolus
n=148 Participants
|
Continuous Infusion
n=136 Participants
|
|---|---|---|---|---|
|
Net Fluid Loss
|
2334.8 mL
Standard Deviation 2006.4
|
3747.4 mL
Standard Deviation 2716.1
|
2996.7 mL
Standard Deviation 2490.5
|
3120.6 mL
Standard Deviation 2504.2
|
SECONDARY outcome
Timeframe: Through 72 hoursPopulation: Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Outcome measures
| Measure |
Low Intensification
n=120 Participants
|
High Intensification
n=122 Participants
|
Q 12 Hour Bolus
n=129 Participants
|
Continuous Infusion
n=113 Participants
|
|---|---|---|---|---|
|
Net Fluid Loss
|
3575.2 mL
Standard Deviation 2634.8
|
4898.9 mL
Standard Deviation 3478.5
|
4236.7 mL
Standard Deviation 3207.6
|
4249.2 mL
Standard Deviation 3104.3
|
Adverse Events
Q 12 Hour Bolus
Continuous Infusion
Low Intensification
High Intensification
Serious adverse events
| Measure |
Q 12 Hour Bolus
n=156 participants at risk
|
Continuous Infusion
n=152 participants at risk
|
Low Intensification
n=151 participants at risk
|
High Intensification
n=157 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
10.9%
17/156
Only Serious Adverse Events were collected for this study
|
11.8%
18/152
Only Serious Adverse Events were collected for this study
|
13.2%
20/151
Only Serious Adverse Events were collected for this study
|
9.6%
15/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Cardiac Failure Acute
|
8.3%
13/156
Only Serious Adverse Events were collected for this study
|
3.9%
6/152
Only Serious Adverse Events were collected for this study
|
6.0%
9/151
Only Serious Adverse Events were collected for this study
|
6.4%
10/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Ventricular Tachycardia
|
4.5%
7/156
Only Serious Adverse Events were collected for this study
|
2.6%
4/152
Only Serious Adverse Events were collected for this study
|
4.6%
7/151
Only Serious Adverse Events were collected for this study
|
2.5%
4/157
Only Serious Adverse Events were collected for this study
|
|
Renal and urinary disorders
Renal Failure
|
3.2%
5/156
Only Serious Adverse Events were collected for this study
|
3.9%
6/152
Only Serious Adverse Events were collected for this study
|
4.6%
7/151
Only Serious Adverse Events were collected for this study
|
2.5%
4/157
Only Serious Adverse Events were collected for this study
|
|
Vascular disorders
Hypotension
|
4.5%
7/156
Only Serious Adverse Events were collected for this study
|
5.9%
9/152
Only Serious Adverse Events were collected for this study
|
7.3%
11/151
Only Serious Adverse Events were collected for this study
|
3.2%
5/157
Only Serious Adverse Events were collected for this study
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
3/156
Only Serious Adverse Events were collected for this study
|
0.00%
0/152
Only Serious Adverse Events were collected for this study
|
1.3%
2/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.6%
4/156
Only Serious Adverse Events were collected for this study
|
0.66%
1/152
Only Serious Adverse Events were collected for this study
|
2.6%
4/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Cardiac Arrest
|
1.9%
3/156
Only Serious Adverse Events were collected for this study
|
2.0%
3/152
Only Serious Adverse Events were collected for this study
|
2.0%
3/151
Only Serious Adverse Events were collected for this study
|
1.9%
3/157
Only Serious Adverse Events were collected for this study
|
|
Infections and infestations
Sepsis
|
1.9%
3/156
Only Serious Adverse Events were collected for this study
|
2.6%
4/152
Only Serious Adverse Events were collected for this study
|
3.3%
5/151
Only Serious Adverse Events were collected for this study
|
1.3%
2/157
Only Serious Adverse Events were collected for this study
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.9%
3/156
Only Serious Adverse Events were collected for this study
|
3.3%
5/152
Only Serious Adverse Events were collected for this study
|
4.0%
6/151
Only Serious Adverse Events were collected for this study
|
1.3%
2/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Angina Pectoris
|
1.3%
2/156
Only Serious Adverse Events were collected for this study
|
0.66%
1/152
Only Serious Adverse Events were collected for this study
|
1.3%
2/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Atrial Fibrillation
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
1.3%
2/152
Only Serious Adverse Events were collected for this study
|
1.3%
2/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Atrial Tachycardia
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
0.66%
1/152
Only Serious Adverse Events were collected for this study
|
0.66%
1/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
2.0%
3/152
Only Serious Adverse Events were collected for this study
|
1.3%
2/151
Only Serious Adverse Events were collected for this study
|
1.3%
2/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Cardiogenic Shock
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
0.00%
0/152
Only Serious Adverse Events were collected for this study
|
0.66%
1/151
Only Serious Adverse Events were collected for this study
|
0.00%
0/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Myocardial Infarction
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
0.00%
0/152
Only Serious Adverse Events were collected for this study
|
0.00%
0/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
0.66%
1/152
Only Serious Adverse Events were collected for this study
|
1.3%
2/151
Only Serious Adverse Events were collected for this study
|
0.00%
0/157
Only Serious Adverse Events were collected for this study
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
0.00%
0/152
Only Serious Adverse Events were collected for this study
|
0.66%
1/151
Only Serious Adverse Events were collected for this study
|
0.00%
0/157
Only Serious Adverse Events were collected for this study
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.64%
1/156
Only Serious Adverse Events were collected for this study
|
0.00%
0/152
Only Serious Adverse Events were collected for this study
|
0.66%
1/151
Only Serious Adverse Events were collected for this study
|
0.00%
0/157
Only Serious Adverse Events were collected for this study
|
|
Vascular disorders
Shock Haemorrhagic
|
0.00%
0/156
Only Serious Adverse Events were collected for this study
|
0.66%
1/152
Only Serious Adverse Events were collected for this study
|
0.66%
1/151
Only Serious Adverse Events were collected for this study
|
0.00%
0/157
Only Serious Adverse Events were collected for this study
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/156
Only Serious Adverse Events were collected for this study
|
0.66%
1/152
Only Serious Adverse Events were collected for this study
|
0.00%
0/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.3%
2/156
Only Serious Adverse Events were collected for this study
|
1.3%
2/152
Only Serious Adverse Events were collected for this study
|
2.0%
3/151
Only Serious Adverse Events were collected for this study
|
0.64%
1/157
Only Serious Adverse Events were collected for this study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
2/156
Only Serious Adverse Events were collected for this study
|
3.9%
6/152
Only Serious Adverse Events were collected for this study
|
2.0%
3/151
Only Serious Adverse Events were collected for this study
|
3.2%
5/157
Only Serious Adverse Events were collected for this study
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place