NCT04237636

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

January 19, 2020

Last Update Submit

December 28, 2020

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • \> 18 years
  • Subjects undergoing heart valve replacement surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (10)

  • 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.

    PMID: 16034904BACKGROUND

  • 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.

    PMID: 25673427BACKGROUND

  • 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.

    PMID: 15563569BACKGROUND

  • 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. doi: 10.1161/CIRCULATIONAHA.106.635573. Epub 2006 Nov 6.

    PMID: 17088458BACKGROUND

  • 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.

    PMID: 22186469BACKGROUND

  • 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. doi: 10.1097/01.asn.0000130340.93930.dd.

    PMID: 15153571BACKGROUND

  • Jorge-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.

    PMID: 26700607BACKGROUND

  • 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. doi: 10.1186/cc5713.

    PMID: 17331245BACKGROUND

  • 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. doi: 10.1161/CIRCULATIONAHA.106.677070.

    PMID: 17846294BACKGROUND

  • Yan 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.

    PMID: 36960471DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Chong Lei, MD, PhD

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD& PhD

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

February 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

CN(1)