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

NCT06091982 | Completed Results DMC

• 1 other identifier: 01.202308.101
• Study Type: observational
• Target: 1,113
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury (AKI); Cardiac Surgery; Renal Replacement Therapy; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  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 Outcomes (2)

• ICU Stay Over 5 Days

  Time of ICU length of stay measured with days, up to 4 weeks

• Mechanical Ventilation > 48 Hours

  Time of ventilator usage measure with hours, up to 4 weeks

Study Arms (2)

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)

AKI non RRT

Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.

Interventions

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)

AKI-RRT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Related Publications (13)

• Yi Q, Li K, Jian Z, Xiao YB, Chen L, Zhang Y, Ma RY. Risk Factors for Acute Kidney Injury after Cardiovascular Surgery: Evidence from 2,157 Cases and 49,777 Controls - A Meta-Analysis. Cardiorenal Med. 2016 May;6(3):237-50. doi: 10.1159/000444094. Epub 2016 Mar 17.

  PMID: 27275160 BACKGROUND

• Thakar CV, Arrigain S, Worley S, Yared JP, Paganini EP. A clinical score to predict acute renal failure after cardiac surgery. J Am Soc Nephrol. 2005 Jan;16(1):162-8. doi: 10.1681/ASN.2004040331. Epub 2004 Nov 24.

  PMID: 15563569 BACKGROUND

• Vives M, Hernandez A, Parramon F, Estanyol N, Pardina B, Munoz A, Alvarez P, Hernandez C. Acute kidney injury after cardiac surgery: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2019 Jul 2;12:153-166. doi: 10.2147/IJNRD.S167477. eCollection 2019.

  PMID: 31303781 BACKGROUND

• Olivero JJ, Olivero JJ, Nguyen PT, Kagan A. Acute kidney injury after cardiovascular surgery: an overview. Methodist Debakey Cardiovasc J. 2012 Jul-Sep;8(3):31-6. doi: 10.14797/mdcj-8-3-31.

  PMID: 23227284 BACKGROUND

• Carrascal Y, Laguna G, Blanco M, Paneda L, Segura B. Acute Kidney Injury after Heart Valve Surgery in Elderly Patients: any Risk Factors to Modify? Braz J Cardiovasc Surg. 2021 Feb 1;36(1):1-9. doi: 10.21470/1678-9741-2019-0483.

  PMID: 33113315 BACKGROUND

• Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.

  PMID: 23394211 BACKGROUND

• Bove T, Calabro MG, Landoni G, Aletti G, Marino G, Crescenzi G, Rosica C, Zangrillo A. The incidence and risk of acute renal failure after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):442-5. doi: 10.1053/j.jvca.2004.05.021.

  PMID: 15365924 BACKGROUND

• Liu C, Zhang HT, Yue LJ, Li ZS, Pan K, Chen Z, Gu SP, Pan T, Pan J, Wang DJ. Risk factors for mortality in patients undergoing continuous renal replacement therapy after cardiac surgery. BMC Cardiovasc Disord. 2021 Oct 21;21(1):509. doi: 10.1186/s12872-021-02324-8.

  PMID: 34674651 BACKGROUND

• Oh TK, Song IA. Postoperative acute kidney injury requiring continuous renal replacement therapy and outcomes after coronary artery bypass grafting: a nationwide cohort study. J Cardiothorac Surg. 2021 Oct 26;16(1):315. doi: 10.1186/s13019-021-01704-7.

  PMID: 34702324 BACKGROUND

• Zou H, Hong Q, Xu G. Early versus late initiation of renal replacement therapy impacts mortality in patients with acute kidney injury post cardiac surgery: a meta-analysis. Crit Care. 2017 Jun 17;21(1):150. doi: 10.1186/s13054-017-1707-0.

  PMID: 28623953 BACKGROUND

• Borisov AS, Malov AA, Kolesnikov SV, Lomivorotov VV. Renal Replacement Therapy in Adult Patients After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2273-2286. doi: 10.1053/j.jvca.2019.02.023. Epub 2019 Feb 15. No abstract available.

  PMID: 30871949 BACKGROUND

• Matsuura R, Iwagami M, Moriya H, Ohtake T, Hamasaki Y, Nangaku M, Doi K, Kobayashi S, Noiri E. The Clinical Course of Acute Kidney Disease after Cardiac Surgery: A Retrospective Observational Study. Sci Rep. 2020 Apr 16;10(1):6490. doi: 10.1038/s41598-020-62981-1.

  PMID: 32300140 BACKGROUND

• Thongprayoon C, Cheungpasitporn W, Shah IK, Kashyap R, Park SJ, Kashani K, Dillon JJ. Long-term Outcomes and Prognostic Factors for Patients Requiring Renal Replacement Therapy After Cardiac Surgery. Mayo Clin Proc. 2015 Jul;90(7):857-64. doi: 10.1016/j.mayocp.2015.03.026.

  PMID: 26141328 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Prieta Adriane MD
• Organization: National Cardivascular Center Harapan Kita

prietaadriane@gmail.com

+62 21 5684093

Study Officials

• Bambang Widyantoro, PhD

  Institutional Review Board

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Anesthesiologist

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 23, 2023
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)