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NCT Number: NCT04922866

Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection

Acute kidney injury (AKI) is a severe complication after liver resection and is associated with morbidity and mortality. The incidence of postoperative AKI is significantly higher in elderly patients, especially in those with comorbidities.

There is currently limited evidence on the incidence and associations of postoperative AKI in elderly patients following liver resection.

This study will evaluate the incidence and associations of AKI in elderly patients after liver resection and its impact on postoperative mortality.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital, Beijing, Beijing Municipality, China

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About this study

The occurrence of postoperative AKI is independently associated with 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.

Although elderly patients account for approximately 25% of surgical procedures, the incidence and associations of AKI in this group of patients are rarely understood.

Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.

This study is a retrospective cohort study, aim to access risk factors of postoperative AKI and its association with outcomes. The investigators will develop and validate a predictive model for postoperative AKI.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients aged ≥65 years
  • Benign and malignant liver diseases

Exclusion criteria

  • Emergency operation
  • Liver transplantation

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Postoperative acute kidney injury

    Time frame: postoperative seven days

    Postoperative acute kidney injury is 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.

Secondary outcomes

  1. Incidence of postoperative AKI

    Time frame: postoperative seven days

    collection of clinical data in the medical record and follow-up update

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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