Clinical trial NCT06091982: Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury
Official title: The Need of Renal Replacement Therapy and In-Hospital Mortality Incidence In Patients With Cardiac Surgery Associated Acute Kidney Injury: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury (AKI)
Cardiac Surgery
Renal Replacement Therapy
Mortality
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 1113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cardiac surgery patients with condition of acute kidney injury postoperative, which underwent the surgery from January 2020 to December 2022.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: From ICU admission postoperative until the death date during hospital care, assessed up to 3 months
Secondary outcomes:
measure: ICU Stay Over 5 Days
timeFrame: Time of ICU length of stay measured with days, up to 4 weeks
measure: Mechanical Ventilation > 48 Hours
timeFrame: Time of ventilator usage measure with hours, up to 4 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center
state: DKI Jakarta
Study officials:
affiliation: Institutional Review Board
name: Bambang Widyantoro, PhD
role: STUDY_CHAIR
References:
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