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

December 28, 2020 updated by: chonglei, Xijing Hospital

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.

Study Overview

Status

Completed

Conditions

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.

  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.

Study Type

Observational

Enrollment (Actual)

3392

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KY20192157-C-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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