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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

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.

Condition or disease
Acute Kidney Injury Children Cardiac Surgery

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy




Primary Outcome Measures :
  1. Early prediction of postoperative acute renal injury with TEE [ Time Frame: Intraoperative period ]
    Intraoperative renal blood flow assessment with TEE

  2. 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

  3. Acute kidney injury [ Time Frame: Postoperative 1 week ]
    AKI is staged according to KDIGO



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

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


Contacts
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Contact: Mustafa Kemal Arslantas, Assoc Prof +905052242119 mkarslantas@gmail.com
Contact: Pelin Corman Dincer, Ass. Prof +905425270011 pelincorman@yahoo.com

Locations
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Turkey
Marmara University Pendik Education and Research Hospital Recruiting
Istanbul, Turkey
Contact: Mustafa Kemal Arslantas, Assoc.Prof    +905052242119    mkarslantas@gmail.com   
Contact: Pelin Corman Dincer, Ass Prof    +905425270011    pelincorman@yahoo.com   
Principal Investigator: Gulbin Tore Altun, MD         
Principal Investigator: Alper Kararmaz, Prof         
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Alper Kararmaz, Prof Marmara University Pendik Education and Research Hospital

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Responsible Party: Mustafa Kemal Arslantas, Assoc. Prof. Dr, Marmara University
ClinicalTrials.gov Identifier: NCT03608956     History of Changes
Other Study ID Numbers: 09.2017.642
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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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

Keywords provided by Mustafa Kemal Arslantas, Marmara University:
regional oximetry
cerebral oximetry

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases