Acute Kidney Injury
Conditions
Keywords
Acute Kidney Injury (AKI), Cardiac Surgery, Renal Replacement Therapy, Mortality
Brief summary
The goal of this study is to analyse the relation of severe acute kidney injury post cardiac surgery which characterised by the need of renal replacement therapy, with in-hospital postoperative mortality incidence. The main question it aims to answer: To compare between patients complicated with acute kidney injury and exposure of renal replacement therapy (AKI-RRT) and patients complicated with acute kidney injury which does not require renal replacement therapy, in associated with in-hospital postoperative mortality.
Detailed description
Type of study: observational study Participant population: Post cardiac surgery patients with condition of acute kidney injury postoperative, will be assigned into 2 groups, based on their exposure to renal replacement therapy. Those groups are: Group AKI-RRT : patients with AKI postoperative with exposure of renal replacement therapy Group AKI non RRT : patients with AKI postoperative, with no exposure to renal replacement therapy Researchers will compare group AKI-RRT and AKI non RRT to analyse the association to postoperative mortality, and other factors that related to mortality variable.
Interventions
PROCEDURERenal Replacement Therapy (RRT)
Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
Sponsors
National Cardiovascular Center Harapan Kita Hospital Indonesia
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are at least 18 years old, underwent cardiac surgery in Harapan Kita National Cardiovascular Center from January 2020 to December 2022. 2. Patients with condition was complicated with Acute Kidney Injury (AKI) which was characterised by an increase in serum creatinine \> 0.3 mg/dL or \> 150% of the preoperative serum creatinine value, which was checked within 12 hours post-operative. 3. All patients' data is recorded in the medical records unit.
Exclusion criteria
1. Patients with previous history of dialysis or renal failure in dialysis. 2. Incomplete or loss of patients' data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From ICU admission postoperative until the death date during hospital care, assessed up to 3 months | Number of participants who died of any cause during postoperative care in hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Stay Over 5 Days | Time of ICU length of stay measured with days, up to 4 weeks | Number of participants which the postoperative ICU length of stay more than 5 days |
| Mechanical Ventilation > 48 Hours | Time of ventilator usage measure with hours, up to 4 weeks | Number of participants which the postoperative usage of mechanical ventilation (breathing ventilator) more than 48 hours |
Countries
Indonesia
Participant flow
Recruitment details
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
Pre-assignment details
2.670 patients excluded due to incomplete/missing reports/data, with previous RRT before surgery, and not complicated with CSA-AKI
Participants by arm
| Arm | Count |
|---|---|
| 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. | 302 |
| AKI Non RRT Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy. | 811 |
| Total | 1,113 |
Baseline characteristics
| Characteristic | AKI RRT | Total | AKI Non RRT |
|---|---|---|---|
| Age, Customized > 60 years old | 196 Participants | 415 Participants | 219 Participants |
| Creatinine level > 3.0 mg/dL | 81 Participants | 132 Participants | 51 Participants |
| Diabetes | 121 Participants | 361 Participants | 240 Participants |
| History of stroke | 118 Participants | 433 Participants | 315 Participants |
| Hypertension | 118 Participants | 433 Participants | 315 Participants |
| Postoperative diuretic therapy | 217 Participants | 807 Participants | 590 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Renal disease | 10 Participants | 17 Participants | 7 Participants |
| Sex: Female, Male Female | 81 Participants | 251 Participants | 170 Participants |
| Sex: Female, Male Male | 221 Participants | 862 Participants | 641 Participants |
| Smoker | 62 Participants | 194 Participants | 132 Participants |
| Type of Surgery CABG | 118 Participants | 543 Participants | 425 Participants |
| Type of Surgery Congenital | 14 Participants | 53 Participants | 39 Participants |
| Type of Surgery Mixed Valves | 38 Participants | 104 Participants | 66 Participants |
| Type of Surgery Other surgeries | 49 Participants | 114 Participants | 65 Participants |
| Type of Surgery Valves | 83 Participants | 299 Participants | 216 Participants |
| Use of inotropes and vasoactives > 2 drugs | 129 Participants | 280 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 96 / 302 | 34 / 811 |
| other Total, other adverse events | 129 / 302 | 151 / 811 |
| serious Total, serious adverse events | 104 / 302 | 46 / 811 |
Outcome results
Primary
Mortality
Number of participants who died of any cause during postoperative care in hospital
Time frame: From ICU admission postoperative until the death date during hospital care, assessed up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AKI-RRT | Mortality | 96 Participants |
| AKI Non RRT | Mortality | 34 Participants |
Comparison: Bivariable analysis of both groupsp-value: <0.000195% CI: [7, 16.2]Chi-squared
Comparison: Multivariable analysisp-value: <0.000195% CI: [2, 6.1]Regression, Logistic
Secondary
ICU Stay Over 5 Days
Number of participants which the postoperative ICU length of stay more than 5 days
Time frame: Time of ICU length of stay measured with days, up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AKI-RRT | ICU Stay Over 5 Days | 183 Participants |
| AKI Non RRT | ICU Stay Over 5 Days | 89 Participants |
p-value: <0.000195% CI: [9.1, 17.1]Chi-squared
p-value: <0.000195% CI: [2.8, 7]Regression, Logistic
Secondary
Mechanical Ventilation > 48 Hours
Number of participants which the postoperative usage of mechanical ventilation (breathing ventilator) more than 48 hours
Time frame: Time of ventilator usage measure with hours, up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AKI-RRT | Mechanical Ventilation > 48 Hours | 198 Participants |
| AKI Non RRT | Mechanical Ventilation > 48 Hours | 88 Participants |
p-value: <0.000195% CI: [11.3, 21.6]Chi-squared
p-value: <0.000195% CI: [3.3, 8.2]Regression, Logistic