Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery

NCT03798067 | Unknown DMC

• 1 other identifier: XYFY-2018-0008
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute kidney injury (AKI) is a common complication of cardiac surgery, which seriously affects the postoperative complication rate and mortality of patients.Acute kidney injury occurs in 5-30% of patients after cardiac surgery, but severe acute kidney injury requiring dialysis is relatively rare.At present, the diagnosis of AKI is based on serum creatinine (Scr) or urine volume. However, the changes of serum creatinine value have hysteresis, and the increase of serum creatinine level lags behind kidney injury for 48 \~ 72 h.Some drugs can also affect creatinine levels.Urine volume is also affected by many factors.Due to the lack of sensitivity and specificity of SCr, it is very important to find and adopt new early AKI markers.Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.Previous experiments have shown that placing a multi-plane esophageal probe into the human stomach through the esophagus can monitor the changes of left renal blood flow before, during and after cardiovascular surgery extracorporeal circulation, and has good repeatability, which may become an effective means to monitor renal blood flow during cardiovascular surgery. In conclusion, this study intends to use esophageal ultrasound as a means to monitor renal blood flow, observe the changes of intraoperative renal hemodynamic indexes, and use KDIGO ( Kidney Disease:Improving Global Outcomes)as the standard of renal injury to explore the correlation between intraoperative hemodynamic changes and postoperative AKI, providing a new perspective for the pathophysiological study of AKI after cardiopulmonary bypass.

Conditions

Postoperative Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• AUC(RI)

  ROC curve（receiver operating characteristic curve）will be drawn according to the incidence of renal resistance index (RI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value(Area Under Curve) will be statistically analyzed.

  RI monitored 30 minutes after cardiopulmonary bypass termination

• AUC(PI)

  ROC curve will be drawn according to the incidence of renal pulsatility index (PI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value will be statistically analyzed.

  PI monitored 30 minutes after cardiopulmonary bypass termination

Secondary Outcomes (5)

• Changes in biomarkers

  Before surgery and at 4 hours, 12 hours, and 24 hours after surgery

• Length of ICU stay

  an average of 2 days

• Length of hospital stay

  an average of 10 days

• Use of renal replacement therapy

  Until 3 months after discharge

• Survival rate

  At 1, 7 and 30 days after discharge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 patients undergoing elective cardiac surgery in the Affiliated Hospital of Xuzhou Medical University.

You may qualify if:

• Aged between 18 and 70;
• Elective cardiopulmonary bypass for patients undergoing cardiac surgery

You may not qualify if:

• Acute myocardial infarction surgery within 7 days
• Emergency surgery
• Known renal artery stenosis, renal malformation;Renal failure
• Congenital esophageal malformation
• Patients with previous history of stomach and esophagus should avoid intraoperative esophageal ultrasound examination
• Existing acute kidney injury, kidney transplantation, chronic kidney disease and glomerular filtration rate less than 30 ml/min,
• Pregnancy

Sponsors & Collaborators

• Xuzhou Medical University: lead

Related Publications (4)

• Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90.

  PMID: 22163121 RESULT

• Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.

  PMID: 28869251 RESULT

• Bellos I, Pergialiotis V, Kontzoglou K. Renal resistive index as predictor of acute kidney injury after major surgery: A systematic review and meta-analysis. J Crit Care. 2019 Apr;50:36-43. doi: 10.1016/j.jcrc.2018.11.001. Epub 2018 Nov 15.

  PMID: 30471559 RESULT

• Regolisti G, Maggiore U, Cademartiri C, Belli L, Gherli T, Cabassi A, Morabito S, Castellano G, Gesualdo L, Fiaccadori E. Renal resistive index by transesophageal and transparietal echo-doppler imaging for the prediction of acute kidney injury in patients undergoing major heart surgery. J Nephrol. 2017 Apr;30(2):243-253. doi: 10.1007/s40620-016-0289-2. Epub 2016 Mar 19.

  PMID: 26995003 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Creatinine, eGFR: blood was collected preoperatively, 4h postoperatively, and at least 3 days postoperatively in the morning. TIMP-2,IGPBP-7:Urine samples were collected before and after surgery at 4, 12 and 24 hours

Study Officials

• Jin Dong Liu, M.S

  The Affiliated Hospital of Xuzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Jin Dong Liu, M.S

CONTACT

+86-13951355136; liujindong1818@163.com

Hui Zhang

CONTACT

+8615996938739; 504099077@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 9, 2019
• Study Start: January 2, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 9, 2019

Record last verified: 2018-12