Validation of Transesophageal Echocardiography (TEE) to Measure Renal Resistive Index and to Predict Renal Injury
| Tracking Information | |||||
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| First Received Date ICMJE | June 25, 2010 | ||||
| Last Updated Date | December 20, 2012 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Validation of resistive index using TEE [ Time Frame: Prior to surgical incision and postop ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT01151774 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of Transesophageal Echocardiography (TEE) to Measure Renal Resistive Index and to Predict Renal Injury | ||||
| Official Title ICMJE | Validation of Transesophageal Echocardiography With to Measure Renal Resistive Index and to Predict Acute Kidney Injury | ||||
| Brief Summary | The study doctors are trying to determine if the TEE measurements from your stomach are helpful in measuring the blood flow to the kidneys. |
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| 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 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The subject sample will consist of patients undergoing cardiac, vascular and major abdominal surgeries. |
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| Condition ICMJE | Decreased Vascular Flow to Kidneys | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 89 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01151774 | ||||
| Other Study ID Numbers ICMJE | 0120100024 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Anesthesia, University of Medicine and Dentistry New Jersey | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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