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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
Sponsor:
Information provided by (Responsible Party):
Mustafa Kemal Arslantas, Marmara University

Tracking Information
First Submitted Date June 28, 2018
First Posted Date August 1, 2018
Last Update Posted Date August 1, 2018
Actual Study Start Date May 1, 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Renal Oxygen Saturation and Its Association With Acute Renal Injury
Official Title RENAL BLOOD FLOW MEASUREMENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY:RENAL OXYGEN SATURATION AND ITS ASSOCIATION WITH ACUTE RENAL INJURY
Brief Summary Peri-operative renal dysfunction is a major mortality and morbidity cause following cardiac and major vascular surgery. 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. Near infrared spectroscopy (NIRS) assesses tissue oxygenation especially cerebral regional oxygen saturation. The benefit of NIRS followups of cerebral and somatic (liver, kidney, mesentery) oxygenation in pediatric cardiovascular surgery patients are demonstrated by studies.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pediatric patients who meet the inclusion criteria and who will undergo cardiac surgery in our hospital will be included in the study.
Condition
  • Acute Kidney Injury
  • Children
  • Cardiac Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 31, 2018)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Mustafa Kemal Arslantas, Assoc Prof +905052242119 mkarslantas@gmail.com
Contact: Pelin Corman Dincer, Ass. Prof +905425270011 pelincorman@yahoo.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03608956
Other Study ID Numbers 09.2017.642
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement Not Provided
Responsible Party Mustafa Kemal Arslantas, Marmara University
Study Sponsor Marmara University
Collaborators Not Provided
Investigators
Principal Investigator: Alper Kararmaz, Prof Marmara University Pendik Education and Research Hospital
PRS Account Marmara University
Verification Date July 2018