EpidemiologyNCT03789747
Acute Kidney Injury After Craniotomy
An observational study of Epidemiology and Acute Kidney Injury, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidemiology, Acute Kidney Injury, Risk Factor
- How many people
- 143 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients underwent craniotomy
- admitted into ICU ward and the ICU length of stay ≥24h
Who cannot join
- Age< 18 years;
- Patients with pre-existing acute kidney injury (AKI) and chronic kidney disease undergoing long-term renal replacement therapy (RRT) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epidemiology, Acute Kidney Injury, Risk Factor
- Being tested
- As a observational study, there is no intervention.
- Keywords
- incidence, prognosis, acute kidney injury, risk factor, post-craniotomy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
As a observational study, there is no intervention.Other
As a observational study, there is no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and outcome of AKI after Craniotomy
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.
Measured: during hospitalization
Secondary outcomes (1)
Risk factors for AKI after Craniotomy
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.
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpidemiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfang Zhou, Beijing Tiantan Hospital
- Investigators
- Jianxin Zhou, MD, Study director, Beijing Tiantan HospitalGuangzhi Shi, MD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789747
- Sponsor's protocol ID
- Beijing Tiantan Hospital
- Status last verified
- Feb 2024
- First submitted
- 11 May 2017
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Acute Kidney Injury After Craniotomy: a Single-Center Experience
- ClinicalTrials.gov ID
- NCT03789747
- Acronym / sponsor ID
- Beijing Tiantan Hospital
- Conditions
- Epidemiology, Acute Kidney Injury, Risk Factor
- Keywords
- incidence, prognosis, acute kidney injury, risk factor, post-craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients underwent craniotomy
- admitted into ICU ward and the ICU length of stay ≥24h
Key exclusion criteria (2 listed)
- Age< 18 years;
- Patients with pre-existing acute kidney injury (AKI) and chronic kidney disease undergoing long-term renal replacement therapy (RRT) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| As a observational study, there is no intervention.As a observational study, there is no intervention. | Other | – |
Primary outcome
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.
1 secondary outcome
Risk factors for AKI after Craniotomy
Time frame: during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Epidemiology
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Enrolling by invitationObservational study
Carolina Breast Cancer Study Phase 4
Breast Cancer, Breast Neoplasms
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxin Zhou, MD study director
Beijing Tiantan Hospital
Guangzhi Shi, MD study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology and Acute Kidney Injury, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and outcome of AKI after Craniotomy (time frame: during hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.