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

Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia (Other)
Overall Status
Recruiting
CT.gov ID
NCT06091982
Collaborator
(none)
1,113
1
3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Renal Replacement Therapy (RRT)

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1113 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The Need of Renal Replacement Therapy and In-Hospital Mortality Incidence In Patients With Cardiac Surgery Associated Acute Kidney Injury: Retrospective Study
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cardiovascular Center Jakarta DKI Jakarta Indonesia 11420

Sponsors and Collaborators

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prieta Adriane MD, MD Anesthesiologist, National Cardiovascular Center Harapan Kita Hospital Indonesia
ClinicalTrials.gov Identifier:
NCT06091982
Other Study ID Numbers:
  • 01.202308.101
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prieta Adriane MD, MD Anesthesiologist, National Cardiovascular Center Harapan Kita Hospital Indonesia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023