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Completed

NCT Number: NCT03789747

Acute Kidney Injury After Craniotomy

The aim of this study was to investigate the incidence, risk factors and prognosis of acute kidney injury (AKI) in critically ill patients after craniotomy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tian Tan hospital

Beijing, Beijing Municipality, 100050, China

About this study

This was a prospective, single-center, cohort study that included adult patients who were admitted to the ICU of Beijing Tiantan Hospital from January 2017 to December 2018 after craniotomy and had a stay in the ICU for ≥ 24 hours (patients with preoperative AKI were excluded). Data collected included patient demographics (age, gender, underlying diseases, baseline serum creatinine, etc.), primary diagnosis, perioperative information, disease severity scores, as well as the occurrence of hypernatremia and hyperchloremia within 48 hours after ICU admission. For patients with AKI, pre-AKI sepsis and shock, and the recovery of renal function were recorded. All patients were followed until discharge, and information about prognosis was recorded. Multivariate regression analysis was used to identify the risk factors of AKI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients underwent craniotomy
  • admitted into ICU ward and the ICU length of stay ≥24h

Exclusion criteria

  • Age< 18 years;
  • Patients with pre-existing acute kidney injury (AKI) and chronic kidney disease undergoing long-term renal replacement therapy (RRT) .

Treatment and study plan

As a observational study, there is no intervention.

Other

As a observational study, there is no intervention.

Primary outcomes

  1. Incidence and outcome of AKI after Craniotomy

    Time frame: during hospitalization

    All adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018 were screened for acute kidney injury.

Secondary outcomes

  1. Risk factors for AKI after Craniotomy

    Time frame: during hospitalization

    Logistic regression analysis was employed to assess the risk factors for AKI. Variables with a significance level of P<0.2 in univariate analysis and clinical relevance were included as adjustment factors in the regression analysis model. The calibration of the model was evaluated using the Hosmer-Lemeshow goodness-of-fit test.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Incidence and Risk Factors of Acute Kidney Injury After Craniotomy: a Single-Center Experience

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 31, 2018
Registry last updated
Feb 11, 2025

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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