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

October 15, 2024 updated by: Prieta Adriane MD, National Cardiovascular Center Harapan Kita Hospital Indonesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 11420
        • National Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From ICU admission postoperative until the death date during hospital care, assessed up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time of ICU length of stay measured with days, up to 4 weeks
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
Time of ventilator usage measure with hours, up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

  • Study Chair: Bambang Widyantoro, PhD, Institutional Review Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01.202308.101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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