Renal Oxygen Saturation and Its Association With Acute Renal Injury

December 11, 2025 updated by: Mustafa Kemal Arslantas, Marmara University

RENAL BLOOD FLOW MEASUREMENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY:RENAL OXYGEN SATURATION AND ITS ASSOCIATION WITH ACUTE RENAL INJURY

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Istanbul, Turkey, Turkey (Türkiye)
        • Marmara University Pendik Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 10 years (Child)

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alper Kararmaz, Prof, Marmara University Pendik Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2019

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.2017.642

Drug and device information, study documents

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

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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