Renal Oxygen Saturation and Its Association With Acute Renal Injury
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|ClinicalTrials.gov Identifier: NCT03608956|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease|
|Acute Kidney Injury Children Cardiac Surgery|
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 :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||RENAL BLOOD FLOW MEASUREMENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY:RENAL OXYGEN SATURATION AND ITS ASSOCIATION WITH ACUTE RENAL INJURY|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Early prediction of postoperative acute renal injury with TEE [ Time Frame: Intraoperative period ]Intraoperative renal blood flow assessment with TEE
- 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
- Acute kidney injury [ Time Frame: Postoperative 1 week ]AKI is staged according to KDIGO
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608956
|Contact: Mustafa Kemal Arslantas, Assoc Profemail@example.com|
|Contact: Pelin Corman Dincer, Ass. Proffirstname.lastname@example.org|
|Marmara University Pendik Education and Research Hospital||Recruiting|
|Contact: Mustafa Kemal Arslantas, Assoc.Prof +905052242119 email@example.com|
|Contact: Pelin Corman Dincer, Ass Prof +905425270011 firstname.lastname@example.org|
|Principal Investigator: Gulbin Tore Altun, MD|
|Principal Investigator: Alper Kararmaz, Prof|
|Principal Investigator:||Alper Kararmaz, Prof||Marmara University Pendik Education and Research Hospital|