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Decreased Vascular Flow to KidneysNCT01151774

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

An observational study of Decreased Vascular Flow to Kidneys, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Decreased Vascular Flow to Kidneys
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2010to Jun 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Hospital

    Newark, New Jersey, 07101

Other trials in United States

About this study

Official title: 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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of resistive index using TEE

    Measured: Prior to surgical incision and postop

Secondary outcomes (1)
  1. Correlate post operative creatinine, BUN and GFR levels with intraoperative resistance index

    The investigators hypothesize that there is a correlation between abnormal TEE resistive index measures, intraoperative events and post operative renal function studies.

    Measured: Daily levels postoperatively to day 5 or discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: study entered twice, please see protocol 0120110047

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151774
Sponsor's protocol ID
0120100024
Status last verified
Feb 2016
First submitted
25 Jun 2010
Last updated
2 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Decreased Vascular Flow to Kidneys, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of resistive index using TEE (time frame: Prior to surgical incision and postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.

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