Trial Outcomes & Findings for Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial) (NCT NCT02568722)
NCT ID: NCT02568722
Last Updated: 2024-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3019 participants
Primary outcome timeframe
90 days following study randomization.
Results posted on
2024-10-18
Participant Flow
Participant milestones
| Measure |
Standard RRT Initiation
RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
Standard RRT initiation: In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:
serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
|
Accelerated RRT Initiation
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
Accelerated RRT initiation: A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
|
|---|---|---|
|
Overall Study
STARTED
|
1507
|
1512
|
|
Overall Study
Withdrew Consent
|
18
|
9
|
|
Overall Study
Randomized Non-eligible
|
19
|
31
|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
|
Overall Study
COMPLETED
|
1462
|
1465
|
|
Overall Study
NOT COMPLETED
|
45
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard RRT Initiation
n=1462 Participants
RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
Standard RRT initiation: In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:
serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
|
Accelerated RRT Initiation
n=1465 Participants
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
Accelerated RRT initiation: A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
|
Total
n=2927 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 13.3 • n=1462 Participants
|
64.5 years
STANDARD_DEVIATION 14.2 • n=1465 Participants
|
64.5 years
STANDARD_DEVIATION 13.8 • n=2927 Participants
|
|
Sex: Female, Male
Female
|
467 Participants
n=1462 Participants
|
470 Participants
n=1465 Participants
|
937 Participants
n=2927 Participants
|
|
Sex: Female, Male
Male
|
995 Participants
n=1462 Participants
|
995 Participants
n=1465 Participants
|
1990 Participants
n=2927 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
North America
|
497 participants
n=1462 Participants
|
497 participants
n=1465 Participants
|
994 participants
n=2927 Participants
|
|
Region of Enrollment
Europe
|
572 participants
n=1462 Participants
|
574 participants
n=1465 Participants
|
1146 participants
n=2927 Participants
|
|
Region of Enrollment
New Zealand
|
80 participants
n=1462 Participants
|
82 participants
n=1465 Participants
|
162 participants
n=2927 Participants
|
|
Region of Enrollment
Brazil
|
4 participants
n=1462 Participants
|
4 participants
n=1465 Participants
|
8 participants
n=2927 Participants
|
|
Region of Enrollment
China
|
111 participants
n=1462 Participants
|
115 participants
n=1465 Participants
|
226 participants
n=2927 Participants
|
|
Region of Enrollment
Australia
|
198 participants
n=1462 Participants
|
193 participants
n=1465 Participants
|
391 participants
n=2927 Participants
|
|
Weight - kg
|
87.9 kg
STANDARD_DEVIATION 25.1 • n=1462 Participants • Number analyzed differs from number enrolled due to missing data.
|
87.8 kg
STANDARD_DEVIATION 26.6 • n=1465 Participants • Number analyzed differs from number enrolled due to missing data.
|
87.8 kg
STANDARD_DEVIATION 25.8 • n=2927 Participants • Number analyzed differs from number enrolled due to missing data.
|
|
Serum creatinine - mg/dl
|
1.3 mg/dl
STANDARD_DEVIATION 1.0 • n=1462 Participants
|
1.4 mg/dl
STANDARD_DEVIATION 1.0 • n=1465 Participants
|
1.3 mg/dl
STANDARD_DEVIATION 1.0 • n=2927 Participants
|
|
Estimated glomerular filtration rate - ml/min/1.73 m2
|
67.3 ml/min/1.73 m2
STANDARD_DEVIATION 29.8 • n=1462 Participants
|
66.0 ml/min/1.73 m2
STANDARD_DEVIATION 29.8 • n=1465 Participants
|
66.7 ml/min/1.73 m2
STANDARD_DEVIATION 29.8 • n=2927 Participants
|
|
Preexisting conditions - no./total no. (%) - Chronic kidney disease
|
626 Participants
n=1462 Participants
|
658 Participants
n=1465 Participants
|
1284 Participants
n=2927 Participants
|
|
Preexisting conditions - no./total no. (%) - Hypertension
|
823 Participants
n=1462 Participants
|
814 Participants
n=1465 Participants
|
1637 Participants
n=2927 Participants
|
|
Preexisting conditions - no./total no. (%) - Diabetes mellitus
|
459 Participants
n=1461 Participants • Data for this variable was missing for one participant in the standard arm.
|
439 Participants
n=1465 Participants • Data for this variable was missing for one participant in the standard arm.
|
898 Participants
n=2926 Participants • Data for this variable was missing for one participant in the standard arm.
|
|
Preexisting conditions - no./total no. (%) - Heart failure
|
204 Participants
n=1461 Participants • Data for this variable was missing for one participant in the standard arm.
|
204 Participants
n=1465 Participants • Data for this variable was missing for one participant in the standard arm.
|
408 Participants
n=2926 Participants • Data for this variable was missing for one participant in the standard arm.
|
|
Preexisting conditions - no./total no. (%) - Coronary artery disease
|
328 Participants
n=1461 Participants • Data for this variable was missing for one participant in the standard arm.
|
320 Participants
n=1465 Participants • Data for this variable was missing for one participant in the standard arm.
|
648 Participants
n=2926 Participants • Data for this variable was missing for one participant in the standard arm.
|
|
Preexisting conditions - no./total no. (%) - Liver disease
|
165 Participants
n=1461 Participants • Data for this variable was missing for one participant in the standard arm.
|
172 Participants
n=1465 Participants • Data for this variable was missing for one participant in the standard arm.
|
337 Participants
n=2926 Participants • Data for this variable was missing for one participant in the standard arm.
|
|
Preexisting conditions - no./total no. (%) - Metastatic cancer
|
84 Participants
n=1462 Participants
|
77 Participants
n=1465 Participants
|
161 Participants
n=2927 Participants
|
|
Preexisting conditions - no./total no. (%) - Hematologic cancer
|
83 Participants
n=1462 Participants
|
87 Participants
n=1465 Participants
|
170 Participants
n=2927 Participants
|
|
Preexisting conditions - no./total no. (%) - HIV infection or AIDS
|
13 Participants
n=1462 Participants
|
13 Participants
n=1465 Participants
|
26 Participants
n=2927 Participants
|
|
Admission category - no. (%) - Scheduled surgery
|
184 Participants
n=1462 Participants
|
207 Participants
n=1465 Participants
|
391 Participants
n=2927 Participants
|
|
Admission category - no. (%) - Unscheduled surgery
|
289 Participants
n=1462 Participants
|
285 Participants
n=1465 Participants
|
574 Participants
n=2927 Participants
|
|
Admission category - no. (%) - Medical
|
989 Participants
n=1462 Participants
|
973 Participants
n=1465 Participants
|
1962 Participants
n=2927 Participants
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Cardiopulmonary bypass
|
118 Participants
n=1462 Participants
|
112 Participants
n=1465 Participants
|
230 Participants
n=2927 Participants
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Aortic aneurysm repair
|
74 Participants
n=1461 Participants • Missing data
|
71 Participants
n=1465 Participants • Missing data
|
145 Participants
n=2926 Participants • Missing data
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Other vascular surgery
|
77 Participants
n=1462 Participants
|
76 Participants
n=1465 Participants
|
153 Participants
n=2927 Participants
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Major trauma
|
55 Participants
n=1462 Participants
|
62 Participants
n=1465 Participants
|
117 Participants
n=2927 Participants
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Obstetric complication
|
5 Participants
n=1462 Participants
|
5 Participants
n=1465 Participants
|
10 Participants
n=2927 Participants
|
|
Hospital-acquired risk factor AKI previous wk (no./total no. (%)) - Exposure radiocontrast material
|
375 Participants
n=1460 Participants • Missing data
|
382 Participants
n=1463 Participants • Missing data
|
757 Participants
n=2923 Participants • Missing data
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Receipt of aminoglycoside
|
148 Participants
n=1458 Participants • Missing data
|
154 Participants
n=1463 Participants • Missing data
|
302 Participants
n=2921 Participants • Missing data
|
|
Hospital-acquired risk factor for AKI in previous wk - no./total no. (%) - Receipt of amphotericin B
|
12 Participants
n=1460 Participants • Missing data
|
9 Participants
n=1464 Participants • Missing data
|
21 Participants
n=2924 Participants • Missing data
|
|
Clinical condition at randomization - Sepsis - no. (%)
|
834 Participants
n=1462 Participants
|
855 Participants
n=1465 Participants
|
1689 Participants
n=2927 Participants
|
|
Clinical condition at randomization - Septic shock - no. (%)
|
643 Participants
n=1462 Participants
|
640 Participants
n=1465 Participants
|
1283 Participants
n=2927 Participants
|
|
Clinical condition at randomization - SAPS II value
|
59.4 units on a scale
STANDARD_DEVIATION 17.4 • n=1462 Participants
|
58.1 units on a scale
STANDARD_DEVIATION 17.4 • n=1465 Participants
|
58.8 units on a scale
STANDARD_DEVIATION 17.4 • n=2927 Participants
|
|
Clinical condition at randomization - SOFA score
|
11.8 SOFA score (0-24)
STANDARD_DEVIATION 3.6 • n=1462 Participants
|
11.6 SOFA score (0-24)
STANDARD_DEVIATION 3.6 • n=1465 Participants
|
11.7 SOFA score (0-24)
STANDARD_DEVIATION 3.6 • n=2927 Participants
|
|
Clinical condition at randomization - Mechanical ventilation - no. (%)
|
1148 Participants
n=1462 Participants
|
1103 Participants
n=1465 Participants
|
2251 Participants
n=2927 Participants
|
|
Clinical condition at randomization - Vasoactive support - no. (%)
|
1052 Participants
n=1462 Participants
|
1008 Participants
n=1465 Participants
|
2060 Participants
n=2927 Participants
|
|
Clinical condition at randomization - Serum creatinine - mg/dl
|
3.4 mg/dl
STANDARD_DEVIATION 1.6 • n=1462 Participants
|
3.6 mg/dl
STANDARD_DEVIATION 1.7 • n=1465 Participants
|
3.5 mg/dl
STANDARD_DEVIATION 1.65 • n=2927 Participants
|
|
Clinical condition at randomization - Serum potassium - mmol/liter
|
4.5 mmol/liter
STANDARD_DEVIATION 0.8 • n=1462 Participants
|
4.5 mmol/liter
STANDARD_DEVIATION 0.8 • n=1465 Participants
|
4.5 mmol/liter
STANDARD_DEVIATION 0.8 • n=2927 Participants
|
|
Clinical condition at randomization - Serum bicarbonate - mmol/liter
|
19.5 mmol/liter
STANDARD_DEVIATION 4.5 • n=1462 Participants
|
19.7 mmol/liter
STANDARD_DEVIATION 4.7 • n=1465 Participants
|
19.6 mmol/liter
STANDARD_DEVIATION 4.6 • n=2927 Participants
|
|
Clinical condition at randomization - Median urinary output (IQR) - ml/24 hr
|
478 ml/24 hr
n=1462 Participants
|
450 ml/24 hr
n=1465 Participants
|
462 ml/24 hr
n=2927 Participants
|
|
Clinical condition at randomization- Oliguria or anuria - no./total no. (%)
|
618 Participants
n=1420 Participants • Missing data
|
647 Participants
n=1415 Participants • Missing data
|
1265 Participants
n=2835 Participants • Missing data
|
|
Clinical condition at randomization- Median cumulative fluid balance (IQR) - ml
|
2819 ml/ 24 hr
n=1462 Participants
|
2581 ml/ 24 hr
n=1465 Participants
|
2691.5 ml/ 24 hr
n=2927 Participants
|
PRIMARY outcome
Timeframe: 90 days following study randomization.Outcome measures
| Measure |
Standard RRT Initiation
n=1462 Participants
RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
Standard RRT initiation: In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:
serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
|
Accelerated RRT Initiation
n=1465 Participants
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
Accelerated RRT initiation: A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
|
|---|---|---|
|
All-cause Mortality.
|
639 Participants
|
643 Participants
|
SECONDARY outcome
Timeframe: 90 days following study randomization.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days following study randomization.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days following study randomization.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days following study randomization.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days following study randomization.Defined as death, RRT dependence or sustained reduction in kidney function (defined as eGFR \< 75% baseline eGFR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from randomization through day 28.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from randomization through day 28.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from randomization through day 28.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from randomization through day 90.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured in-hospital and at day 28.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at day 90 and at day 365.A measure of health-related quality of life and patient utility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from baseline through day 365.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at day 365.Outcome measures
Outcome data not reported
Adverse Events
Standard RRT Initiation
Serious events: 8 serious events
Other events: 245 other events
Deaths: 639 deaths
Accelerated RRT Initiation
Serious events: 15 serious events
Other events: 346 other events
Deaths: 643 deaths
Serious adverse events
| Measure |
Standard RRT Initiation
n=1489 participants at risk
RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
Standard RRT initiation: In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:
serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
|
Accelerated RRT Initiation
n=1503 participants at risk
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
Accelerated RRT initiation: A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia during RRT
|
0.07%
1/1489 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.13%
2/1503 • Number of events 2 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
CVC - associated bloodstream infection
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Hemorrhage at site of CVC insertion
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Hemothorax following CVC insertion
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Major bleeding
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Pneumothorax following CVC insertion
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.13%
2/1503 • Number of events 3 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Vascular disorders
RRT - associated hypotension
|
0.27%
4/1489 • Number of events 4 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.33%
5/1503 • Number of events 5 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
General disorders
Severe hypocalcemia (Ionized calcium < 0.90 mmol/L)
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
General disorders
Other
|
0.20%
3/1489 • Number of events 3 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.13%
2/1503 • Number of events 2 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
Other adverse events
| Measure |
Standard RRT Initiation
n=1489 participants at risk
RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
Standard RRT initiation: In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:
serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
|
Accelerated RRT Initiation
n=1503 participants at risk
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
Accelerated RRT initiation: A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
8.8%
131/1489 • Number of events 188 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
5.5%
83/1503 • Number of events 112 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Cardiac disorders
Arrhythmia
|
1.5%
23/1489 • Number of events 29 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
2.5%
37/1503 • Number of events 45 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Nervous system disorders
Seizure
|
0.00%
0/1489 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Bleeding
|
0.34%
5/1489 • Number of events 5 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.67%
10/1503 • Number of events 10 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Allergic reaction
|
0.07%
1/1489 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.07%
1/1503 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
General disorders
Decreased phosphate (<0.5 mmol/liter)
|
4.2%
62/1489 • Number of events 68 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
7.5%
112/1503 • Number of events 124 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
General disorders
Decreased potassium (<3.0 mmol/liter)
|
2.3%
34/1489 • Number of events 40 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
2.3%
34/1503 • Number of events 43 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
General disorders
Decreased ionized calcium (<0.90 mmol/ liter)
|
4.4%
66/1489 • Number of events 80 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
5.3%
80/1503 • Number of events 102 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax or hemothorax
|
0.13%
2/1489 • Number of events 2 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.27%
4/1503 • Number of events 5 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Vascular disorders
Thrombus (as confirmed on ultrasonography)
|
0.34%
5/1489 • Number of events 5 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.20%
3/1503 • Number of events 3 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Surgical and medical procedures
Arterial puncture
|
0.13%
2/1489 • Number of events 2 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.20%
3/1503 • Number of events 3 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
Infections and infestations
Bloodstream infection
|
0.07%
1/1489 • Number of events 1 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
0.47%
7/1503 • Number of events 7 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
|
General disorders
Other
|
1.3%
19/1489 • Number of events 20 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
1.4%
21/1503 • Number of events 24 • Through study completion, 90 days following study randomization
All-Cause Mortality was pre-specified to be monitored/assessed only in participants who completed the study. AEs and SAEs were reported from the entire randomized population minus those who withdrew consent
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60