Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

NCT ID: NCT04967105

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-20

Study Completion Date

2022-01-30

Brief Summary

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The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.

Detailed Description

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Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.

Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.

Despite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.

This study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.

Conditions

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Postoperative Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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elderly patients following liver resection

elderly patients (aged ≥60 years) scheduled for any type of liver resection due to benign or malignant hepatobiliary diseases

Near-infrared spectroscopy

Intervention Type DEVICE

Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.

Interventions

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Near-infrared spectroscopy

Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection

Exclusion Criteria

* Emergency surgery
* Liver transplantation
* Preoperative hemodialysis
* BMI \> 30
* Renal depth (distance from the capsule of the kidney to the skin surface) \> 4 cm
* Unable or failed to sign the informed consent
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Changgeng Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weidong Mi, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PLAGH-AOC-003

Identifier Type: -

Identifier Source: org_study_id

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