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

NCT03323203 | Completed DMC

• 1 other identifier: KY20172070-1
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Postoperative acute kidney injury (AKI)

  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 Outcomes (4)

• Length of mechanical ventilation

  Postoperative day 0-day 7

• Length of ICU stay

  Postoperative day 0-day 7

• Length of hospital stay

  Postoperative day 0-day 30

• Adverse events in 30 days

  Postoperative day 0-day 30

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are going to have double valves replacement surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 37726660 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hailong Dong, PhD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.& Ph.D.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: January 4, 2018
• Primary Completion: December 7, 2019
• Study Completion: December 7, 2019
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)