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.
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.
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.
- Conditions
- Decreased Vascular Flow to Kidneys
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of resistive index using TEE
Measured: Prior to surgical incision and postop
Secondary outcomes (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.
- First posted28 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: study entered twice, please see protocol 0120110047
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decreased Vascular Flow to KidneysStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Jackson, MD, JD, Principal investigator, UMDNJ-NJMS
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Transesophageal Echocardiography With to Measure Renal Resistive Index and to Predict Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01151774
- Acronym / sponsor ID
- 0120100024
- Conditions
- Decreased Vascular Flow to Kidneys
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study entered twice, please see protocol 0120110047
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study doctors are trying to determine if the TEE measurements from your stomach are helpful in measuring the blood flow to the kidneys.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject sample will consist of patients undergoing cardiac, vascular and major abdominal surgeries.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of resistive index using TEE
Time frame: Prior to surgical incision and postop
1 secondary outcome
Correlate post operative creatinine, BUN and GFR levels with intraoperative resistance index
Time frame: Daily levels postoperatively to day 5 or discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Jackson, MD, JD principal investigator
UMDNJ-NJMS
1 site in 1 country: see every site and its status.
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.