Acute Kidney InjuryNCT06091982
Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury
An observational study of Acute Kidney Injury, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Renal Replacement Therapy (RRT)
- Type of treatment
- Surgery or procedure
- How many people
- 1,113 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 30 Jun 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cardiac surgery patients with condition of acute kidney injury postoperative, which underwent the surgery from January 2020 to December 2022.
Who may be able to join
- 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.
Who cannot join
- Patients with previous history of dialysis or renal failure in dialysis.
- Incomplete or loss of patients' data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Renal Replacement Therapy (RRT)
- Keywords
- Acute Kidney Injury (AKI), Cardiac Surgery, Renal Replacement Therapy, Mortality
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Replacement Therapy (RRT)Procedure or surgery
Renal Support therapy which consist of procedure of intermittent hemodialysis (IHD) or continuous veno-venous hemofiltration/hemodialysis/hemodiafiltration (CVVH/CVVHD/CVVHDF)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of participants who died of any cause during postoperative care in hospital
Measured: From ICU admission postoperative until the death date during hospital care, assessed up to 3 months
Secondary outcomes (2)
ICU Stay Over 5 Days
Number of participants which the postoperative ICU length of stay more than 5 days
Measured: Time of ICU length of stay measured with days, up to 4 weeks
Mechanical Ventilation > 48 Hours
Number of participants which the postoperative usage of mechanical ventilation (breathing ventilator) more than 48 hours
Measured: Time of ventilator usage measure with hours, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,113 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prieta Adriane MD, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Bambang Widyantoro, PhD, Study chair, Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091982
- Sponsor's protocol ID
- 01.202308.101
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2023
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27275160Thakar 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.
PubMed 15563569Vives 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.
PubMed 31303781Olivero 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.
PubMed 23227284Carrascal 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.
PubMed 33113315Kellum 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.
PubMed 23394211Bove 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.
PubMed 15365924Liu 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.
PubMed 34674651Oh 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.
PubMed 34702324Zou 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.
PubMed 28623953Borisov 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.
PubMed 30871949Matsuura 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.
PubMed 32300140Thongprayoon 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.
PubMed 26141328
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Need of Renal Replacement Therapy and In-Hospital Mortality Incidence In Patients With Cardiac Surgery Associated Acute Kidney Injury: Retrospective Study
- ClinicalTrials.gov ID
- NCT06091982
- Acronym / sponsor ID
- 01.202308.101
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury (AKI), Cardiac Surgery, Renal Replacement Therapy, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,113 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI-RRT | – | Procedure: Renal Replacement Therapy (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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cardiac surgery patients with condition of acute kidney injury postoperative, which underwent the surgery from January 2020 to December 2022.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with previous history of dialysis or renal failure in dialysis.
- Incomplete or loss of patients' data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | AKI-RRT |
Primary outcome
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
2 secondary outcomes
ICU Stay Over 5 Days
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27275160Yi 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.
- Background: PubMed 15563569Thakar 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.
- Background: PubMed 31303781Vives 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.
- Background: PubMed 23227284Olivero 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.
- Background: PubMed 33113315Carrascal 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.
- Background: PubMed 23394211Kellum 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.
- Background: PubMed 15365924Bove 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.
- Background: PubMed 34674651Liu 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.
- Background: PubMed 34702324Oh 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.
- Background: PubMed 28623953Zou 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.
- Background: PubMed 30871949Borisov 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.
- Background: PubMed 32300140Matsuura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bambang Widyantoro, PhD study chair
Institutional Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From ICU admission postoperative until the death date during hospital care, assessed up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06091982, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.