A Clinical Score to Predict Acute Kidney Injury After Heart Valve Replacement Surgery

Acute Kidney Injury Clinical Trial

Official title:

A Clinical Score to Predict Acute Kidney Injury After Heart Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237636
• Other study ID #: KY20192157-C-1
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3392
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• > 18 years

• Subjects undergoing heart valve replacement surgery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Birnie 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. — View Citation

Brown 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. — View Citation

Huen 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. Review. — View Citation

Jorge-Monjas P, Bustamante-Munguira J, Lorenzo M, Heredia-Rodríguez M, Fierro I, Gómez-Sánchez E, Hernandez A, Álvarez FJ, Bermejo-Martin JF, Gómez-Pesquera E, Gómez-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. — View Citation

Lassnigg 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. — View Citation

Mehta 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. Epub 2006 Nov 6. — View Citation

Mehta 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. — 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. Epub 2004 Nov 24. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD003590. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during postoperative day 7