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Completed

NCT Number: NCT03323203

Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in 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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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