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Trial record 27 of 221 for:    Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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

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ClinicalTrials.gov Identifier: NCT03323203
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
chonglei, Xijing Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Kidney Injury Device: FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA

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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : December 15, 2018

Intervention Details:
  • Device: FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA
    Tissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe.


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Length of mechanical ventilation [ Time Frame: Postoperative day 0-day 7 ]
    Time between intubation and extubation

  2. Length of ICU stay [ Time Frame: Postoperative day 0-day 7 ]
    Days between end of operation and departure of ICU

  3. Length of hospital stay [ Time Frame: Postoperative day 0-day 30 ]
    Days between end of operation and hospital discharge

  4. Adverse events in 30 days [ Time Frame: Postoperative day 0-day 30 ]
    Clinical events since hospital discharge



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are going to have double valves replacement surgery
Criteria

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

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): NCT03323203


Contacts
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Contact: HaiLong Dong, PhD +86 13669226699 dongh369@126.com

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Hui Zhang, M.D.    86-15991700956    zhanghuia309@163.com   
Principal Investigator: Hailong Dong, PhD         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Hailong Dong, PhD Xijing Hospital

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Responsible Party: chonglei, M.D.& Ph.D., Xijing Hospital
ClinicalTrials.gov Identifier: NCT03323203     History of Changes
Other Study ID Numbers: KY20172070-1
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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