Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury

Completed

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Renal Replacement Therapy (RRT)

• Registration Number: NCT06091982
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Results First Submitted: 2024-07-08
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1113

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AKI-RRT	Renal Replacement Therapy (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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cardiovascular Center; 🇮🇩 Jakarta, DKI Jakarta, Indonesia