Use of Transesophageal Echocardiography to Measure Intraop Renal Resistive Index and Predict Acute Renal Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01547065
First received: March 2, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The investigators hypothesize that transesophageal echocardiography is a valid method to obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a correlation between abnormal TEE resistive index measurements, intraoperative events and post-operative creatinine changes


Condition
Subjects Undergoing Cardiac or Major Surgery Where TEE is Used as a Matter of Routine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Transesophageal Echocardiography to Measure Intraoperative Renal Resistive Index and Predict Acute Renal Injury

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • renal resistive index [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post operative creatinine changes [ Time Frame: 5 days post operatively ] [ Designated as safety issue: No ]
    subjects BUN and creatinine levels will be recorded daily


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The significant morbidity and mortality associated with acute kidney injury in critical care patients and after cardiac surgery is well-known. Studies have demonstrated between 1 to 30% postoperative mortality and even higher rates of up to 70% when patients develop renal failure and require dialysis. Even small increases in creatinine between 0 to 0.5 mg/dl can result in a greater than two-fold rise in 30-day mortality.1 Despite efforts to improve outcome, there has been no proven effective pharmacological interventions to treat acute kidney failure. Most recommendations are aimed at prevention by identifying high-risk patients, avoiding nephrotoxic drugs and minimizing intraoperative hypotensive insults.2

There are few studies that have examined the maintenance of adequate renal perfusion by measuring renal blood flow using transesophageal echocardiography (TEE) during cardiopulmonary bypass.3, 4 Yang et al. examined the left renal artery of 60 patients using TEE during cardiac surgery and evaluated the feasibility of using TEE as a method to measure renal blood flow intraoperatively.4 Although they were only able to include 60% of the subjects due to technical difficulties, they did demonstrate less than 10% variability between measurements and therefore good reproducibility using TEE. However, renal blood flow may not be the best method to predict sufficient renal perfusion. Renal autoregulation is not preserved under general anesthesia even with the maintenance of adequate mean arterial blood pressure and cardiac output. Renal blood flow is further worsened by hemodilution and hypothermia. In addition, due to its pulsatile nature, the diameters of the renal arteries vary during the cardiac cycle and are a source of calculation error when determining renal blood flow as a function of renal blood velocity and arterial diameter.2

Renal resistive index (RI) is a measure of intrarenal hemodynamics that is calculated using the blood flow velocities of segmental or intrarenal vessels and correlates with renal blood flow and renovascular resistance. The renal artery is not used because the flow varies and is inconsistent between systole and diastole. RI becomes elevated in pathological conditions and is associated with increasing creatinine, renal injury and dysfunction.5-7 As blood flow and creatinine clearance decrease through the renal vasculature, the resistive index increases. Resistive index may be a better gauge of renal dysfunction rather than renal blood flow because it is easier to assess and less dependent on obtaining a Doppler beam view that is oriented perfectly parallel to the blood flow.2 Because RI is a ratio of the renal blood flow velocities [RI = (peak systolic velocity - peak end diastolic velocity)/peak systolic velocity], the margin of error created by non-parallel Doppler beams cancels out.

Traditionally, resistive index is obtained by transabdominal Doppler ultrasonography (USG) although there have been transesophageal studies that have used RI as a secondary endpoint when examining renal blood flow.2, 4 There is currently no technique that routinely uses TEE to intraoperatively monitor resistive index as a determination of adequate renal blood perfusion and an indication of renal compromise.8 In addition, while other studies have reported RI as a secondary outcome, no studies have validated the TEE calculation of resistive index compared to the established transabdominal doppler technique.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

potential subjects are those undergoing cardiac or major abdominal or vascular surgery where TEE is standard of care

Criteria

Inclusion Criteria:

  • TEE is part of a anesthetic plan as determined by the anesthesiologist

Exclusion Criteria:

  • Subjects on hemodialysis/peritoneal dialysis
  • Subjects with a contraindication to use of TEE; esophageal stricture, esophageal diverticulum, esophageal tumor, recent esophageal/gastric surgery or radiation to the chest
  • Subjects who are pregnant
  • Subjects with esophageal varices
  • Subjects with bleeding disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547065

Contacts
Contact: Catherine Schoenberg, BSN 973 972-74777 shoenbce@njms.rutgers.edu

Locations
United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07101
Principal Investigator: Douglas Jackson, MD, JD         
Sub-Investigator: Sheldon Goldstein, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Douglas Jackson, MD, JD Rutgers/NJMS
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01547065     History of Changes
Other Study ID Numbers: 0120110047
Study First Received: March 2, 2012
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
TEE and renal resistive index

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014