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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| AKI non RRT | Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mechanical Ventilation > 48 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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Adult cardiac surgery patients with condition of acute kidney injury postoperative, which underwent the surgery from January 2020 to December 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Bambang Widyantoro, PhD | Institutional Review Board | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cardiovascular Center | Jakarta | DKI Jakarta | 11420 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27275160 | Background | 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. | |
| 15563569 | 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. |
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2.670 patients excluded due to incomplete/missing reports/data, with previous RRT before surgery, and not complicated with CSA-AKI
all adult cardiac surgery patients (> 18 years old) with EMRs who were admitted to the cardiac surgery ICU from January 1st , 2020 to December 31st, 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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) |
| FG001 | AKI Non RRT | Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subject number: people
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | AKI Non RRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Subject's age by the time of surgery, whose aged > 60 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Number of participants who died of any cause during postoperative care in hospital | Posted | Count of Participants | Participants | From ICU admission postoperative until the death date during hospital care, assessed up to 3 months |
|
Adverse events that occurred from postoperative period until 1 month after discharged based on electronic medical records
Any additional diagnosis which stated in electronic medical record
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative use of IABP | Cardiac disorders | Non-systematic Assessment | Sign of cardiac dysfunction that lead to the requirement of IABP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Use of inotropes and vasoactive >2 drug | Vascular disorders | Non-systematic Assessment | Hemodynamic unstable |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prieta Adriane MD | National Cardivascular Center Harapan Kita | +62 21 5684093 | 7406 | prietaadriane@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2023 | Oct 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 |
| 31303781 | 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. |
| 23227284 | 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. |
| 33113315 | 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. |
| 23394211 | 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. |
| 15365924 | 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. |
| 34674651 | 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. |
| 34702324 | 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. |
| 28623953 | 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. |
| 30871949 | 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. |
| 32300140 | 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. |
| 26141328 | 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. |
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type of Surgery | Number of participants in one type of surgery | Count of Participants | Participants |
|
| Diabetes | Number of participants who had diabetes history | Count of Participants | Participants |
|
| Hypertension | Number of participant who had hypertensive disease | Count of Participants | Participants |
|
| History of stroke | Number of participants with history of stroke | Count of Participants | Participants |
|
| Smoker | Number of participant who is currently a smoker | Count of Participants | Participants |
|
| Renal disease | Number of participant which has a renal disease | Count of Participants | Participants |
|
| Creatinine level > 3.0 mg/dL | Number of participant with creatinine level postoperative more than 3.0 gr/dL | Count of Participants | Participants |
|
| Use of inotropes and vasoactives > 2 drugs | Number of participants who required inotrope and/or vasoactive drugs more than 2 kinds. | Count of Participants | Participants |
|
| Postoperative diuretic therapy | Number of participants who required diuretic therapy postoperative | Count of Participants | Participants |
|
Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy.
|
|
|
| Secondary | ICU Stay Over 5 Days | Number of participants which the postoperative ICU length of stay more than 5 days | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Time of ventilator usage measure with hours, up to 4 weeks |
|
|
|
|
| 96 |
| 302 |
| 104 |
| 302 |
| 129 |
| 302 |
| EG001 | AKI Non RRT | Post cardiovascular surgery patients with condition of acute kidney injury postoperative; but without exposure of renal replacement therapy. | 34 | 811 | 46 | 811 | 151 | 811 |
|
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Mixed Valves |
|
| Congenital |
|
| Other surgeries |
|
| Odds Ratio, log |
| 4.4 |
| 2-Sided |
| 95 |
| 2.8 |
| 7.0 |
| Superiority |
| Odds Ratio, log |
| 5.2 |
| 2-Sided |
| 95 |
| 3.3 |
| 8.2 |
| Other |