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

NCT ID: NCT03323203

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2019-12-07

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.

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

chonglei

M.D.& Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hailong Dong, PhD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

References

Zhang H, Zhang T, Hou L, Zhao J, Fan Q, Wang L, Lu Z, Dong H, Lei C. Association of intraoperative cerebral and somatic tissue oxygen saturation with postoperative acute kidney injury in adult patients undergoing multiple valve surgery. BMC Anesthesiol. 2023 Sep 19;23(1):319. doi: 10.1186/s12871-023-02279-7.

Reference Type: DERIVED

PMID: 37726660 (View on PubMed)

Other Identifiers

KY20172070-1

Identifier Type: -

Identifier Source: org_study_id