Acute Kidney InjuryNCT04237636
A Clinical Score to Predict Acute Kidney Injury After Heart Valve Replacement Surgery
An observational study of Acute Kidney Injury, run by Xijing Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. The main stay treatment remains preventive with no clear evidence supporting any therapeutic interventions. AKI risk prediction scores are an objective, transparent means of cohort enrichment but are not widely used. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 3,392 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We included adult patients undergoing heart valve replacement surgery between January first, 2014 and December 31, 2018 in a single tertiary hospital (Xijing Hospital, Xi'an, China)
Who may be able to join
- > 18 years
- Subjects undergoing heart valve replacement surgery
Who cannot join
- Pregnancy
- Transplant donor or recipient
- Required preoperative dialysis, with any degree of renal insufficiency (acute or chronic) and patients who had end-stage renal disease (estimated glomerular fltration rate [eGFR] < 15 mL/min /1.73m2 )
- Local anesthesia
- Lack of creatinine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Score to Predict Acute Kidney Injury After Heart Valve Replacement
Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. The main stay treatment remains preventive with no clear evidence supporting any therapeutic interventions. AKI risk prediction scores are an objective, transparent means of cohort enrichment but are not widely used. The purpose of this analysis was to develop and validate a clinical score including pre-,intra-and post-operative predictors that predicted AKI following heart valve replacement surgery. This prediction score allows identification of patients at high risk of AKI and may support decision-making for protective kidney treatment.
Read the detailed description
This study is a single center retrospective observational study designed to to develop and validate a clinical score that predicts AKI after heart valve replacement surgery。 To achieve this goal, patient underwent heart valve replacement surgery will be screened for enrollment eligibility. For the purpose of this analysis, only the first surgical episode was considered. Patients required preoperative dialysis, with any degree of renal insufficiency (acute or chronic) and patients who had end-stage renal disease (estimated glomerular fltration rate [eGFR] < 15 mL/min /1.73m2 )are not included in study.
AKI was classified according to the KDIGO definition[10]. Stage-1 AKI: increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.5μmol/l) or increase to more than or equal to 150% to 200% (1.5≤x<2) from baseline within 7 days. Stage-2 AKI: Increase in serum creatinine to more than 200% to 300% (2≤x<3) from baseline. Stage-3 AKI: Increase in serum creatinine to more than 300% (3≤) from baseline (or serum creatinine of more than or equal to 4.0 mg/dl (≥ 353.6μmol/l) or when the patient commenced RRT.
We selected demographic, preoperative, intra-operative and early postoperative variables considered predictors of AKI.
- The demographic and preoperative factors included age, sex, weight, height; history of smoke, drink, angina, cerebrovascular disease, COPD, peripheral vascular disease, hypertension, valve infection , arrythmia , diabetes mellitus, MI , atrial fibrillation, pulmonary hypertension, previous cardiac surgery; NYHA stage, surgery type , Operative approach and emergency surgery。The latest value before operation: serum creatinine level, haemoglobin, capillary glucose, hemoglobin，WBC, EF, LDL-C , urinary protein, CRP, PCT, ALB, TBIL, PT and Glomerular filtration rate (GFR). History of taking the following drugs before surgery: contrast, nephrotoxic antibiotics, β-blocker, calcium channel blocker, lasix, ACEI, ARB, immunosuppressive, heparin, aspirin, clopidogrel, ticagrelor, digoxin, levosimendan, dopamine, dobutamine, cedilanid, isosorbide dinitrate, isosorbide mononitrate, isoprenaline and NASID.
- The intra-operative factors included cardiopulmonary bypass time, cross-clamp time, transfusion, FFP, VFP, CFP，output and input ; the highest blood glucose, minimum hematocrit, minimum mean arterial pressure, minimum temperature and fluid balance during CPB.
- The postoperative factors included time to extubation, mean ICU and hospital stay and mortality. First measured value after entering ICU: CVP, PH, HB.
We also considered postoperative complications during the intensive care unit included IABP, ECMO, cardiac arrest, arrhythmia, re-intubation, return to ICU，tracheotomy.
- Conditions
- Acute Kidney Injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with post-operative AKI | Patients developing acute kidney injury (AKI) following heart valve replacement surgery. AKI was classified according to the KDIGO definition[10]. Stage-1 AKI: increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.5μmol/l) or increase to more than or equal to 150% to 200% (1.5≤x<2) from baseline within 7 days. Stage-2 AKI: Increase in serum creatinine to more than 200% to 300% (2≤x<3) from baseline. Stage-3 AKI: Increase in serum creatinine to more than 300% (3≤) from baseline (or serum creatinine of more than or equal to 4.0 mg/dl (≥ 353.6μmol/l) or when the patient commenced RRT. | |
| Patients without post-operative AKI | Patients with normal kidney function (without acute kidney injury (AKI)) following heart valve replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an prediction score for AKI(including stage 1,2 and 3)
Development of an simple and easy applicable score based on pre-，intra-and post-operative risk factors to predict postoperative AKI in patients for heart valve replacement surgery
Measured: during postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chonglei, Xijing Hospital
- Investigators
- Chong Lei, MD, PhD, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237636
- Sponsor's protocol ID
- KY20192157-C-1
- Status last verified
- Dec 2020
- First submitted
- 19 Jan 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zacharias M, Gilmore IC, Herbison GP, Sivalingam P, Walker RJ. Interventions for protecting renal function in the perioperative period. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003590. doi: 10.1002/14651858.CD003590.pub2.
PubMed 16034904Birnie K, Verheyden V, Pagano D, Bhabra M, Tilling K, Sterne JA, Murphy GJ; UK AKI in Cardiac Surgery Collaborators. Predictive models for kidney disease: improving global outcomes (KDIGO) defined acute kidney injury in UK cardiac surgery. Crit Care. 2014 Nov 20;18(6):606. doi: 10.1186/s13054-014-0606-x.
PubMed 25673427Thakar 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 15563569Mehta RH, Grab JD, O'Brien SM, Bridges CR, Gammie JS, Haan CK, Ferguson TB, Peterson ED; Society of Thoracic Surgeons National Cardiac Surgery Database Investigators. Bedside tool for predicting the risk of postoperative dialysis in patients undergoing cardiac surgery. Circulation. 2006 Nov 21;114(21):2208-16; quiz 2208. doi: 10.1161/CIRCULATIONAHA.106.635573. Epub 2006 Nov 6.
PubMed 17088458Huen SC, Parikh CR. Predicting acute kidney injury after cardiac surgery: a systematic review. Ann Thorac Surg. 2012 Jan;93(1):337-47. doi: 10.1016/j.athoracsur.2011.09.010.
PubMed 22186469Lassnigg A, Schmidlin D, Mouhieddine M, Bachmann LM, Druml W, Bauer P, Hiesmayr M. Minimal changes of serum creatinine predict prognosis in patients after cardiothoracic surgery: a prospective cohort study. J Am Soc Nephrol. 2004 Jun;15(6):1597-605. doi: 10.1097/01.asn.0000130340.93930.dd.
PubMed 15153571Jorge-Monjas P, Bustamante-Munguira J, Lorenzo M, Heredia-Rodriguez M, Fierro I, Gomez-Sanchez E, Hernandez A, Alvarez FJ, Bermejo-Martin JF, Gomez-Pesquera E, Gomez-Herreras JI, Tamayo E. Predicting cardiac surgery-associated acute kidney injury: The CRATE score. J Crit Care. 2016 Feb;31(1):130-8. doi: 10.1016/j.jcrc.2015.11.004. Epub 2015 Nov 6.
PubMed 26700607Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
PubMed 17331245Brown JR, Cochran RP, Leavitt BJ, Dacey LJ, Ross CS, MacKenzie TA, Kunzelman KS, Kramer RS, Hernandez F Jr, Helm RE, Westbrook BM, Dunton RF, Malenka DJ, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Multivariable prediction of renal insufficiency developing after cardiac surgery. Circulation. 2007 Sep 11;116(11 Suppl):I139-43. doi: 10.1161/CIRCULATIONAHA.106.677070.
PubMed 17846294Yan Y, Gong H, Hu J, Wu D, Zheng Z, Wang L, Lei C. Perioperative parameters-based prediction model for acute kidney injury in Chinese population following valvular surgery. Front Cardiovasc Med. 2023 Mar 7;10:1094997. doi: 10.3389/fcvm.2023.1094997. eCollection 2023.
PubMed 36960471
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Score to Predict Acute Kidney Injury After Heart Valve Replacement
- ClinicalTrials.gov ID
- NCT04237636
- Acronym / sponsor ID
- KY20192157-C-1
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,392 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. The main stay treatment remains preventive with no clear evidence supporting any therapeutic interventions. AKI risk prediction scores are an objective, transparent means of cohort enrichment but are not widely used. The purpose of this analysis was to develop and validate a clinical score including pre-,intra-and post-operative predictors that predicted AKI following heart valve replacement surgery. This prediction score allows identification of patients at high risk of AKI and may support decision-making for protective kidney treatment.
Detailed description
This study is a single center retrospective observational study designed to to develop and validate a clinical score that predicts AKI after heart valve replacement surgery。 To achieve this goal, patient underwent heart valve replacement surgery will be screened for enrollment eligibility. For the purpose of this analysis, only the first surgical episode was considered. Patients required preoperative dialysis, with any degree of renal insufficiency (acute or chronic) and patients who had end-stage renal disease (estimated glomerular fltration rate [eGFR] < 15 mL/min /1.73m2 )are not included in study.
AKI was classified according to the KDIGO definition[10]. Stage-1 AKI: increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.5μmol/l) or increase to more than or equal to 150% to 200% (1.5≤x<2) from baseline within 7 days. Stage-2 AKI: Increase in serum creatinine to more than 200% to 300% (2≤x<3) from baseline. Stage-3 AKI: Increase in serum creatinine to more than 300% (3≤) from baseline (or serum creatinine of more than or equal to 4.0 mg/dl (≥ 353.6μmol/l) or when the patient commenced RRT.
We selected demographic, preoperative, intra-operative and early postoperative variables considered predictors of AKI.
- The demographic and preoperative factors included age, sex, weight, height; history of smoke, drink, angina, cerebrovascular disease, COPD, peripheral vascular disease, hypertension, valve infection , arrythmia , diabetes mellitus, MI , atrial fibrillation, pulmonary hypertension, previous cardiac surgery; NYHA stage, surgery type , Operative approach and emergency surgery。The latest value before operation: serum creatinine level, haemoglobin, capillary glucose, hemoglobin，WBC, EF, LDL-C , urinary protein, CRP, PCT, ALB, TBIL, PT and Glomerular filtration rate (GFR). History of taking the following drugs before surgery: contrast, nephrotoxic antibiotics, β-blocker, calcium channel blocker, lasix, ACEI, ARB, immunosuppressive, heparin, aspirin, clopidogrel, ticagrelor, digoxin, levosimendan, dopamine, dobutamine, cedilanid, isosorbide dinitrate, isosorbide mononitrate, isoprenaline and NASID.
- The intra-operative factors included cardiopulmonary bypass time, cross-clamp time, transfusion, FFP, VFP, CFP，output and input ; the highest blood glucose, minimum hematocrit, minimum mean arterial pressure, minimum temperature and fluid balance during CPB.
- The postoperative factors included time to extubation, mean ICU and hospital stay and mortality. First measured value after entering ICU: CVP, PH, HB.
We also considered postoperative complications during the intensive care unit included IABP, ECMO, cardiac arrest, arrhythmia, re-intubation, return to ICU，tracheotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with post-operative AKI | – | –Patients developing acute kidney injury (AKI) following heart valve replacement surgery. AKI was classified according to the KDIGO definition[10]. Stage-1 AKI: increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.5μmol/l) or increase to more than or equal to 150% to 200% (1.5≤x<2) from baseline within 7 days. Stage-2 AKI: Increase in serum creatinine to more than 200% to 300% (2≤x<3) from baseline. Stage-3 AKI: Increase in serum creatinine to more than 300% (3≤) from baseline (or serum creatinine of more than or equal to 4.0 mg/dl (≥ 353.6μmol/l) or when the patient commenced RRT. |
| Patients without post-operative AKI | – | –Patients with normal kidney function (without acute kidney injury (AKI)) following heart valve replacement surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We included adult patients undergoing heart valve replacement surgery between January first, 2014 and December 31, 2018 in a single tertiary hospital (Xijing Hospital, Xi'an, China)
Key inclusion criteria (2 listed)
- > 18 years
- Subjects undergoing heart valve replacement surgery
Key exclusion criteria (5 listed)
- Pregnancy
- Transplant donor or recipient
- Required preoperative dialysis, with any degree of renal insufficiency (acute or chronic) and patients who had end-stage renal disease (estimated glomerular fltration rate [eGFR] < 15 mL/min /1.73m2 )
- Local anesthesia
- Lack of creatinine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of an prediction score for AKI(including stage 1,2 and 3)
Time frame: during postoperative day 7
Development of an simple and easy applicable score based on pre-，intra-and post-operative risk factors to predict postoperative AKI in patients for heart valve replacement surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Background: PubMed 16034904Zacharias M, Gilmore IC, Herbison GP, Sivalingam P, Walker RJ. Interventions for protecting renal function in the perioperative period. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003590. doi: 10.1002/14651858.CD003590.pub2.
- Background: PubMed 25673427Birnie K, Verheyden V, Pagano D, Bhabra M, Tilling K, Sterne JA, Murphy GJ; UK AKI in Cardiac Surgery Collaborators. Predictive models for kidney disease: improving global outcomes (KDIGO) defined acute kidney injury in UK cardiac surgery. Crit Care. 2014 Nov 20;18(6):606. doi: 10.1186/s13054-014-0606-x.
- 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 17088458Mehta RH, Grab JD, O'Brien SM, Bridges CR, Gammie JS, Haan CK, Ferguson TB, Peterson ED; Society of Thoracic Surgeons National Cardiac Surgery Database Investigators. Bedside tool for predicting the risk of postoperative dialysis in patients undergoing cardiac surgery. Circulation. 2006 Nov 21;114(21):2208-16; quiz 2208. doi: 10.1161/CIRCULATIONAHA.106.635573. Epub 2006 Nov 6.
- Background: PubMed 22186469Huen SC, Parikh CR. Predicting acute kidney injury after cardiac surgery: a systematic review. Ann Thorac Surg. 2012 Jan;93(1):337-47. doi: 10.1016/j.athoracsur.2011.09.010.
- Background: PubMed 15153571Lassnigg A, Schmidlin D, Mouhieddine M, Bachmann LM, Druml W, Bauer P, Hiesmayr M. Minimal changes of serum creatinine predict prognosis in patients after cardiothoracic surgery: a prospective cohort study. J Am Soc Nephrol. 2004 Jun;15(6):1597-605. doi: 10.1097/01.asn.0000130340.93930.dd.
- Background: PubMed 26700607Jorge-Monjas P, Bustamante-Munguira J, Lorenzo M, Heredia-Rodriguez M, Fierro I, Gomez-Sanchez E, Hernandez A, Alvarez FJ, Bermejo-Martin JF, Gomez-Pesquera E, Gomez-Herreras JI, Tamayo E. Predicting cardiac surgery-associated acute kidney injury: The CRATE score. J Crit Care. 2016 Feb;31(1):130-8. doi: 10.1016/j.jcrc.2015.11.004. Epub 2015 Nov 6.
- Background: PubMed 17331245Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
- Background: PubMed 17846294Brown JR, Cochran RP, Leavitt BJ, Dacey LJ, Ross CS, MacKenzie TA, Kunzelman KS, Kramer RS, Hernandez F Jr, Helm RE, Westbrook BM, Dunton RF, Malenka DJ, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Multivariable prediction of renal insufficiency developing after cardiac surgery. Circulation. 2007 Sep 11;116(11 Suppl):I139-43. doi: 10.1161/CIRCULATIONAHA.106.677070.
- Derived from this study: PubMed 36960471Yan Y, Gong H, Hu J, Wu D, Zheng Z, Wang L, Lei C. Perioperative parameters-based prediction model for acute kidney injury in Chinese population following valvular surgery. Front Cardiovasc Med. 2023 Mar 7;10:1094997. doi: 10.3389/fcvm.2023.1094997. eCollection 2023.
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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.
Chong Lei, MD, PhD principal investigator
Air Force Military Medical University, China
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 Xijing Hospital at 1 site in China.
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 2 inclusion and 5 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 29 Dec 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of an prediction score for AKI(including stage 1,2 and 3) (time frame: during postoperative day 7). 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 NCT04237636, which also lists 10 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 29 Dec 2020.