- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789747
Acute Kidney Injury After Craniotomy
February 8, 2025 updated by: Jianfang Zhou, Beijing Tiantan Hospital
Incidence and Risk Factors of Acute Kidney Injury After Craniotomy: a Single-Center Experience
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Beijing Tian tan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients who underwent craniocerebral operation and admitted into intensive care unit (ICU) between January 2017 and December 2018 were consecutively screened.
Patients developed AKI after ICU admission were deemed as cases, and those without AKI were included in the control group.
Description
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) .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
during hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
during hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jianxin Zhou, MD, Beijing Tian tan Hospital
- Study Director: Guangzhi Shi, MD, Beijing Tian tan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
May 11, 2017
First Submitted That Met QC Criteria
December 26, 2018
First Posted (Actual)
December 31, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 8, 2025
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Beijing Tiantan Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
Hospital Civil de GuadalajaraNot yet recruitingAcute Kidney Disease | Acute Kidney Injury (AKI) | Acute Kidney Injuries
-
Sanliurfa Mehmet Akif Inan Education and Research...CompletedIn Acute Kidney InjuryTurkey (Türkiye)
-
University Hospital, GhentWithdrawn
-
Chang Gung Memorial HospitalConmed Pharmaceutical & Bio-Medical CorporationRecruitingAcute Kidney Disease | Acute Kidney Injury (AKI)Taiwan
-
Chinese PLA General HospitalRecruitingPostoperative Acute Kidney InjuryChina
-
Nikola Bradic, MDUnknownAcute Kidney Injury (Nontraumatic)
-
Complexa, Inc.CompletedOpen-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney InjuryAcute Kidney Injury (Nontraumatic)United States
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on As a observational study, there is no intervention.
-
Hospital Universitari Vall d'Hebron Research InstituteCompletedDiabetes Mellitus Type 2 | Alzheimer´s DiseaseSpain
-
Yan FuxiaRecruitingSleep Problems | Delirium - PostoperativeChina
-
Yan FuxiaNot yet recruitingCongenital Heart Disease (CHD) | Sleep Problems | Delirium - Postoperative
-
Nicoline LøkkenCompleted
-
Hospices Civils de LyonRecruitingCystic Fibrosis (CF)France
-
Washington University School of MedicineCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
Ludwig Boltzmann Institute for Lung HealthActive, not recruitingRespiration Disorders | Body Composition, Beneficial | Metabolic HealthAustria
-
Christiana Care Health ServicesAmerican Society for Metabolic and Bariatric SurgeryCompleted
-
Public Health Service South LimburgMaastricht University; National Institute for Public Health and the Environment... and other collaboratorsEnrolling by invitation
-
BERTHILLIER JulienCompletedNeurological Disorder