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Completed

NCT Number: NCT06091982

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cardiovascular Center

Jakarta, DKI Jakarta, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are at least 18 years old, underwent cardiac surgery in Harapan Kita National Cardiovascular Center from January 2020 to December 2022.
  • 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.
  • All patients' data is recorded in the medical records unit.

Exclusion criteria

  • Patients with previous history of dialysis or renal failure in dialysis.
  • Incomplete or loss of patients' data.

Treatment and study plan

Renal Replacement Therapy (RRT)

Procedure

Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)

Primary outcomes

  1. Mortality

    Time frame: 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 outcomes

  1. ICU Stay Over 5 Days

    Time frame: 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

  2. Mechanical Ventilation > 48 Hours

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Registry information

Official study title

The Need of Renal Replacement Therapy and In-Hospital Mortality Incidence In Patients With Cardiac Surgery Associated Acute Kidney Injury: Retrospective Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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