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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323203
• Other study ID #: KY20172070-1
• Status: Completed
• Start date: January 4, 2018
• Est. completion date: December 7, 2019

Study information

• Verified date: December 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 7, 2019
• Est. primary completion date: December 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of mechanical ventilation	Time between intubation and extubation	Postoperative day 0-day 7
Secondary	Length of ICU stay	Days between end of operation and departure of ICU	Postoperative day 0-day 7
Secondary	Length of hospital stay	Days between end of operation and hospital discharge	Postoperative day 0-day 30
Secondary	Adverse events in 30 days	Clinical events since hospital discharge	Postoperative day 0-day 30