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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091982
• Other study ID #: 01.202308.101
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: Prieta Adriane, MD
• Phone: +62215684083
• Email: prietaadriane[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1113
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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)

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/s12872-02 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5. — View Citation

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. — View Citation

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.m — View Citation

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.S16747 — View Citation

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 20 — View Citation

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. Erratum In: Crit — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ICU stay over 5 days	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
Secondary	Mechanical Ventilation > 48 hours	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