Trial Outcomes & Findings for Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury (NCT NCT06091982)
NCT ID: NCT06091982
Last Updated: 2024-10-17
Results Overview
Number of participants who died of any cause during postoperative care in hospital
Recruitment status
COMPLETED
Target enrollment
1113 participants
Primary outcome timeframe
From ICU admission postoperative until the death date during hospital care, assessed up to 3 months
Results posted on
2024-10-17
Participant Flow
all adult cardiac surgery patients (\> 18 years old) with EMRs who were admitted to the cardiac surgery ICU from January 1st , 2020 to December 31st, 2022
2.670 patients excluded due to incomplete/missing reports/data, with previous RRT before surgery, and not complicated with CSA-AKI
Participant milestones
| Measure |
AKI-RRT
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
Renal Replacement Therapy (RRT): Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
|
AKI Non RRT
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
811
|
|
Overall Study
COMPLETED
|
302
|
811
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AKI RRT
n=302 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
|
AKI Non RRT
n=811 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
Total
n=1113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
> 60 years old
|
196 Participants
n=302 Participants
|
219 Participants
n=811 Participants
|
415 Participants
n=1113 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=302 Participants
|
170 Participants
n=811 Participants
|
251 Participants
n=1113 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=302 Participants
|
641 Participants
n=811 Participants
|
862 Participants
n=1113 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Surgery
CABG
|
118 Participants
n=302 Participants
|
425 Participants
n=811 Participants
|
543 Participants
n=1113 Participants
|
|
Type of Surgery
Valves
|
83 Participants
n=302 Participants
|
216 Participants
n=811 Participants
|
299 Participants
n=1113 Participants
|
|
Type of Surgery
Mixed Valves
|
38 Participants
n=302 Participants
|
66 Participants
n=811 Participants
|
104 Participants
n=1113 Participants
|
|
Type of Surgery
Congenital
|
14 Participants
n=302 Participants
|
39 Participants
n=811 Participants
|
53 Participants
n=1113 Participants
|
|
Type of Surgery
Other surgeries
|
49 Participants
n=302 Participants
|
65 Participants
n=811 Participants
|
114 Participants
n=1113 Participants
|
|
Diabetes
|
121 Participants
n=302 Participants
|
240 Participants
n=811 Participants
|
361 Participants
n=1113 Participants
|
|
Hypertension
|
118 Participants
n=302 Participants
|
315 Participants
n=811 Participants
|
433 Participants
n=1113 Participants
|
|
History of stroke
|
118 Participants
n=302 Participants
|
315 Participants
n=811 Participants
|
433 Participants
n=1113 Participants
|
|
Smoker
|
62 Participants
n=302 Participants
|
132 Participants
n=811 Participants
|
194 Participants
n=1113 Participants
|
|
Renal disease
|
10 Participants
n=302 Participants
|
7 Participants
n=811 Participants
|
17 Participants
n=1113 Participants
|
|
Creatinine level > 3.0 mg/dL
|
81 Participants
n=302 Participants
|
51 Participants
n=811 Participants
|
132 Participants
n=1113 Participants
|
|
Use of inotropes and vasoactives > 2 drugs
|
129 Participants
n=302 Participants
|
151 Participants
n=811 Participants
|
280 Participants
n=1113 Participants
|
|
Postoperative diuretic therapy
|
217 Participants
n=302 Participants
|
590 Participants
n=811 Participants
|
807 Participants
n=1113 Participants
|
PRIMARY outcome
Timeframe: From ICU admission postoperative until the death date during hospital care, assessed up to 3 monthsNumber of participants who died of any cause during postoperative care in hospital
Outcome measures
| Measure |
AKI-RRT
n=302 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
Renal Replacement Therapy (RRT): Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
|
AKI Non RRT
n=811 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|---|---|---|
|
Mortality
|
96 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Time of ICU length of stay measured with days, up to 4 weeksNumber of participants which the postoperative ICU length of stay more than 5 days
Outcome measures
| Measure |
AKI-RRT
n=302 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
Renal Replacement Therapy (RRT): Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
|
AKI Non RRT
n=811 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|---|---|---|
|
ICU Stay Over 5 Days
|
183 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Time of ventilator usage measure with hours, up to 4 weeksNumber of participants which the postoperative usage of mechanical ventilation (breathing ventilator) more than 48 hours
Outcome measures
| Measure |
AKI-RRT
n=302 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
Renal Replacement Therapy (RRT): Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
|
AKI Non RRT
n=811 Participants
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|---|---|---|
|
Mechanical Ventilation > 48 Hours
|
198 Participants
|
88 Participants
|
Adverse Events
AKI-RRT
Serious events: 104 serious events
Other events: 129 other events
Deaths: 96 deaths
AKI Non RRT
Serious events: 46 serious events
Other events: 151 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
AKI-RRT
n=302 participants at risk
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
Renal Replacement Therapy (RRT): Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
|
AKI Non RRT
n=811 participants at risk
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|---|---|---|
|
Cardiac disorders
Postoperative use of IABP
|
34.4%
104/302 • Adverse events that occurred from postoperative period until 1 month after discharged based on electronic medical records
Any additional diagnosis which stated in electronic medical record
|
5.7%
46/811 • Adverse events that occurred from postoperative period until 1 month after discharged based on electronic medical records
Any additional diagnosis which stated in electronic medical record
|
Other adverse events
| Measure |
AKI-RRT
n=302 participants at risk
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; and with an exposure of renal replacement therapy (intermittent haemodialysis or continuous renal replacement therapy) which is indicated postoperatively.
Renal Replacement Therapy (RRT): Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
|
AKI Non RRT
n=811 participants at risk
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|---|---|---|
|
Vascular disorders
Use of inotropes and vasoactive >2 drug
|
42.7%
129/302 • Adverse events that occurred from postoperative period until 1 month after discharged based on electronic medical records
Any additional diagnosis which stated in electronic medical record
|
18.6%
151/811 • Adverse events that occurred from postoperative period until 1 month after discharged based on electronic medical records
Any additional diagnosis which stated in electronic medical record
|
Additional Information
Prieta Adriane MD
National Cardivascular Center Harapan Kita
Phone: +62 21 5684093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place