Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery

December 28, 2020 updated by: chonglei, Xijing Hospital

Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery

To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation > 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

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

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing 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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are going to have double valves replacement surgery

Description

Inclusion Criteria:

  • Written informed consent obtained
  • Age ≥18 years of age
  • Double valves replacement surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

  • The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data
  • Preoperative renal dysfunction needs renal replacement therapy
  • Emergency surgery
  • Preoperative intubated patient
  • Unable to cooperate with the study, i.e., mental illness, et al
  • Patients with hemoglobin and anemia
  • Participate in other trials in the prior 3 months
  • Patient refuses to participate in the study
  • Patient is unfit for the study decided by reach stuff

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

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
Postoperative acute kidney injury (AKI)
Time Frame: Seven days postoperatively

AKI is defined as any of the following (Not Graded):

  • K Increase in serum creatinine (SCr) by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or
  • K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
  • K Urine volume o0.5 ml/kg/h for 6 hours.AKI is defined as any of the following (Not Graded):
  • K Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or
  • K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
  • K Urine volume o0.5 ml/kg/h for 6 hours.

AKI is defined as any of the following (Not graded):Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume less than 0.5 ml/kg/h for 6 hours.
Seven days postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of mechanical ventilation
Time Frame: Postoperative day 0-day 7
Time between intubation and extubation
Postoperative day 0-day 7
Length of ICU stay
Time Frame: Postoperative day 0-day 7
Days between end of operation and departure of ICU
Postoperative day 0-day 7
Length of hospital stay
Time Frame: Postoperative day 0-day 30
Days between end of operation and hospital discharge
Postoperative day 0-day 30
Adverse events in 30 days
Time Frame: Postoperative day 0-day 30
Clinical events since hospital discharge
Postoperative day 0-day 30

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.
Xijing Hospital

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: Hailong Dong, PhD, Xijing 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.
January 4, 2018

Primary Completion (Actual)

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.
December 7, 2019

Study Completion (Actual)

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.
December 7, 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).
October 24, 2017

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.
October 24, 2017

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.
October 26, 2017

Study Record Updates

Last Update Posted (Actual)

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 29, 2020

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 28, 2020

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, 2020

More Information

Terms related to this study

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.
  • KY20172070-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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