Association Between Muscular Tissue Oxygen Saturation and AKI in Older Patients Undergoing Major Abdominal Surgery

NCT04954066 | Completed DMC

• 2 other identifiers: lingzi-2021-1Yinlingzi
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate association between muscular oxygen saturation and postoperative acute kidney injury(AKI) in older patients undergoing abdominal surgeries.The investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of AKI and therefore have the potential to be used as therapeutic targets in future.

Conditions

Acute Kidney Injury

Keywords

postoperative acute kidney injury; muscular tissue oxygen saturation; Near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• the incidence of AKI in 7 days

  Postoperative AKI will be diagnosed according to KDIGO(Kidney Disease Improving Global)as one of the following: An increase in serum creatinine by≥0.3 mg/dl ( ≥26.5μmol/l) within 48 h; An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days; Urine volume≤0.5 ml/kg/h for 6 h.

  All the patients will be observed in previous 7 days after surgery for AKI.

Secondary Outcomes (1)

• the incidence of other complications,hospital stays and mortality in 30 days

  All the patients will be followed up within 30 days after surgery.

Eligibility Criteria

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

Study Population

The study intend to enroll elder patients having major abdominal surgeries in our center.

You may qualify if:

• Age ≥65 years old,
• ASA scoreⅠ-Ⅲ,
• Scheduled to undergo a 2-hour-or-longer elective major abdominal surgeries

You may not qualify if:

• Urological surgery or procedure related to renal tissue may be performed during surgeries.
• Nephrectomy or partial nephrectomy was performed before surgeries.
• Preoperative glomerular filtration rate\<30ml/1.73m2, or end-stage renal disease or renal transplant.
• Poor hearing or vision and language barrier impeding postoperative assessment.
• Skin condition incompatible with the adhesive oximetry probe.
• Refuse to participate in the trial.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, 750004, China

Location

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

• N xinli, MD

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: September 11, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 6, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)