- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03608956
Renal Oxygen Saturation and Its Association With Acute Renal Injury
RENAL BLOOD FLOW MEASUREMENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY:RENAL OXYGEN SATURATION AND ITS ASSOCIATION WITH ACUTE RENAL INJURY
Study Overview
Status
Conditions
Detailed Description
Peri-operative renal dysfunction is a major mortality and morbidity cause following cardiac and major vascular surgery. Patients undergoing cardiac surgery with more than one risk factor for postoperative renal insufficiency develop clinical significant renal dysfunction which results in extended length of stay in 1/5 of the patients .At least50% of the postoperative renal dysfunction is associated with development of renal hypoperfusion during cardiopulmonary bypass or aortic cross clamping. Although several intra-operative strategies are proposed for better outcomes, no effective and fast resulting test is available to be done in operating rooms to assess renal functions. Urine and blood markers as serum creatinine, urine output, fractional excretion of sodium and urea are used for early diagnosis of acute renal injury. In this study definition and classification of AKI (acute kidney injury) will be done according to KDIGO (kidney disease improving global outcome) criteria.
Renal perfusion can be assessed by renal artery measurements done by ultrasound imaging.The same assessment can also be done by transesophageal echocardiography (TEE).
Near infrared spectroscopy (NIRS) assesses tissue oxygenation especially cerebral regional oxygen saturation. NIRS measures regional oxygenation (rSO=oxyhemoglobin/ total Hemoglobin) by determining oxy- and deoxy- hemoglobin signals.
The probe placed on frontotemporal region has two sensors and a light source. Data is gained from sensors 3cm apart from the extracranial tissue and 4cm apart from the brain tissue; value is formed from calculation of the difference of these data. The benefit of NIRS followups of cerebral and somatic (liver, kidney, mesentery) oxygenation in pediatric cardiovascular surgery patients are demonstrated by studies.
The investigators aimed to investigate the association of postoperative acute renal injury and the change in peroperative renal blood flow and renal oxygenation values; additionally to establish wether it can be used as a fast responding and efficient method in evaluating renal function in the operating room settings.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mustafa Kemal Arslantas, Assoc Prof
- Phone Number: +905052242119
- Email: mkarslantas@gmail.com
Study Contact Backup
- Name: Pelin Corman Dincer, Ass. Prof
- Phone Number: +905425270011
- Email: pelincorman@yahoo.com
Study Locations
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Istanbul, Turkey
- Recruiting
- Marmara University Pendik Education and Research Hospital
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Contact:
- Mustafa Kemal Arslantas, Assoc.Prof
- Phone Number: +905052242119
- Email: mkarslantas@gmail.com
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Contact:
- Pelin Corman Dincer, Ass Prof
- Phone Number: +905425270011
- Email: pelincorman@yahoo.com
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Principal Investigator:
- Gulbin Tore Altun, MD
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Principal Investigator:
- Alper Kararmaz, Prof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- pediatric patients
- cardiovascular surgery
- Written informed consent
- Peroperative TEE assessment
Exclusion Criteria:
- Patients whose follow up cannot be done with TEE (ie Patients whose body weight is less than 5 kg, patients with esophageal pathologies)
- Patients with renal insufficiency
Patients whose TEE evaluation cannot be done optimally will be left out of the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early prediction of postoperative acute renal injury with TEE
Time Frame: Intraoperative period
|
Intraoperative renal blood flow assessment with TEE
|
Intraoperative period
|
Early prediction of postoperative acute renal injury with transcutaneous renal regional oxygen saturation measured with NIRS
Time Frame: Intraoperative period
|
Renal oxygenation values gained from NIRS monitor during the surgery
|
Intraoperative period
|
Acute kidney injury
Time Frame: Postoperative 1 week
|
AKI is staged according to KDIGO
|
Postoperative 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alper Kararmaz, Prof, Marmara University Pendik Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2017.642
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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