Validation of Transesophageal Echocardiography (TEE) to Measure Renal Resistive Index and to Predict Renal Injury

This study has suspended participant recruitment.
(study entered twice, please see prtocol 0120110047)
Sponsor:
Information provided by (Responsible Party):
Anesthesia, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01151774
First received: June 25, 2010
Last updated: December 20, 2012
Last verified: December 2012

June 25, 2010
December 20, 2012
May 2010
June 2013   (final data collection date for primary outcome measure)
Validation of resistive index using TEE [ Time Frame: Prior to surgical incision and postop ] [ Designated as safety issue: No ]
Validation of resistive index using TEE as compared with the traditional method of TransAbdominal Ultrasound Doppler (TAUD) [ Time Frame: Prior to surgical incision and postop ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01151774 on ClinicalTrials.gov Archive Site
Correlate post operative creatinine, BUN and GFR levels with intraoperative resistance index [ Time Frame: Daily levels postoperatively to day 5 or discharge ] [ Designated as safety issue: No ]
The investigators hypothesize that there is a correlation between abnormal TEE resistive index measures, intraoperative events and post operative renal function studies.
Same as current
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Validation of Transesophageal Echocardiography (TEE) to Measure Renal Resistive Index and to Predict Renal Injury
Validation of Transesophageal Echocardiography With to Measure Renal Resistive Index and to Predict Acute Kidney Injury

The study doctors are trying to determine if the TEE measurements from your stomach are helpful in measuring the blood flow to the kidneys.

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 kidney 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. 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.

There are few studies that have assessed renal blood flow using transesophageal echocardiography (TEE). 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. 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.

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.

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. 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. 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. 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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

The subject sample will consist of patients undergoing cardiac, vascular and major abdominal surgeries.

Decreased Vascular Flow to Kidneys
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
September 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with use of TEE as part of anesthetic plan as clinically determined by anesthesiologist
  • Subjects with no contraindications to use of TEE or transabdominal doppler ultrasonography

Exclusion Criteria:

  • Patients on hemodialysis/peritoneal dialysis
  • Patients with a contraindication to use of TEE i.e.esophageal stricture, esophageal diverticulum, esophageal/gastric tumor, recent esophageal/gastric surgery or radiation to the chest
  • Patients with a contraindication to use of transabdominal doppler ultrasonography
  • Patients who are pregnant
  • patients with esophageal varices
  • Patient with bleeding disorders
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01151774
0120100024
No
Anesthesia, University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
Not Provided
Principal Investigator: Douglas Jackson, MD, JD UMDNJ-NJMS
University of Medicine and Dentistry New Jersey
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP