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Acute Kidney Injury After Craniocerebral Operation

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ClinicalTrials.gov Identifier: NCT03789747
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Jianfang Zhou, Beijing Tiantan Hospital

Brief Summary:
The aim of this study was to report the incidence, severity and risk factors of acute kidney injury (AKI) in patients underwent craniocerebral operation and admitted into intensive care unit (ICU).

Condition or disease Intervention/treatment
Epidemiology Acute Kidney Injury Risk Factor Other: As a observational study, there is no intervention.

Detailed Description:

The study included consecutive adult patients who underwent craniotomy and admitted into intensive care unit (ICU) between January 2017 and December 2018. Patients with congenital renal abnormalities or with stages 4 and 5 chronic kidney disease (CKD) were excluded. Serum creatinine levels were measured before operation, daily after operation until discharged from ICU ward . AKI was depicted according to changes in early postoperative serum creatinine levels and its severity was determined based on the Acute Kidney Injury Network (AKIN) classification. Univariate and multivariate statistical analyses were conducted to determine risk factors for developing AKI.

Preoperative, intraoperative and postoperative variables known to be or could potentially be associated with AKI or other adverse outcomes were collected. Preoperation variables include age, gender, weight, hypertension, diabetes mellitus, hyperuricemia, proteinuria, preoperative serum Cr and estimated estimated glomerular filtration rate (eGFR), left ventricular ejection fraction (LVEF), Charlson Comorbidity Index (CCI), emergency surgery and intravenous contrast. eGFR was calculated with MDRD4 equation. Proteinuria was defined as protein > 15 mg/dl in spot urine specimens. Hyperuricemia was defined as a serum uric acid > 6.6 in women and > 7.0 mg/dl in men. Patients were considered to have diabetes if they were diagnosed with type 1 or type 2 diabetes mellitus before or were taking insulin or oral hypoglycemic agents at the time of cardiac surgery. Hypertension was defined as SBP > 140 mm Hg and/or DBP > 90 mm Hg; or had hypertension history and were taking antihypertensive drugs. LVEF was assessed preoperatively by echocardiography. Charlson Comorbidity Index was used to measure comorbid disease status by calculating the comorbidity score.

Intra-operative variables include surgery type, duration of operation, blood transfusion, urine output,the highest and lowest mean blood pressures, use of radiocontrast agents and dehydrants.

Postoperation variables include hypotension, central venous pressure (CVP), oliguria, re-exploration, mechanical ventilation, use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), radiocontrast agents, dehydrants and RRT. Hypotension was defined as SBP < 90 mm Hg postoperative but before the diagnosis of AKI.

Patients were followed until discharge and all-cause in-hospital mortality was recorded. The length of stay in the ICU and hospital was also recorded. The mortality rates of the patients with or without AKI were compared.

Continuous variables were expressed as mean (SD) and analyzed by unpaired Student's t test. Nonparametric variables were expressed as median and 25-75% percentiles and analyzed by the Mann-Whitney test. Categorical variables were expressed as absolute (n) and relative (%) frequency and were analyzed by chi-square test, as appropriate. A multivariate logistic regression model incorporating all factors associated with AKI in univariate analysis as well as those factors showing a univariate p value < 0.05 was performed to identify associated risk factors with AKI, while Cox Proportional Hazards model was used to identify associated factors with in-hospital mortality and hazard ratios. Risk data are presented as odds or hazard ratios with 95% CIs. p < 0.05 was considered statistically significant for all comparisons. SPSS version 19.0 for windows software was used for the statistical analysis.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Risk Factors of Acute Kidney Injury After Craniocerebral Operation: A Single-Center Experience
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Intervention Details:
  • Other: As a observational study, there is no intervention.
    As a observational study, there is no intervention.


Primary Outcome Measures :
  1. Incidence and outcome of AKI after Craniotomy [ Time Frame: 1 month ]
    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 Outcome Measures :
  1. Risk factors for AKI after Craniotomy [ Time Frame: 1 month ]
    Preoperative, intraoperative and postoperative variables known to be or could potentially be associated with AKI or other adverse outcomes were collected. A multivariate logistic regression model incorporating all factors associated with AKI in univariate analysis as well as those factors showing a univariate p value < 0.05 was performed to identify associated risk factors with AKI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 during their ICU admissions were deemed as cases, and those without AKI were included in the control group.
Criteria

Inclusion Criteria:

  • patients underwent craniocerebral surgery;
  • admitted into ICU ward.

Exclusion Criteria:

  • Age< 18 years;
  • Patients with congenital renal abnormities or with stages 4 and 5 chronic kidney disease (CKD).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789747


Contacts
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Contact: Jianfang Zhou, MD 8610-67096518 zjfyanger@sina.com

Locations
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China, Beijing
Beijing Tian Tan hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Jianfang Zhou, MD    8610-59976518    zjfyanger@sina.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Director: Jianxin Zhou, MD Beijing Tian Tan Hospital
Study Director: Guangzhi Shi, MD Beijing Tian Tan Hospital

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Responsible Party: Jianfang Zhou, Principal investigator, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03789747     History of Changes
Other Study ID Numbers: Beijing Tiantan Hospital
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianfang Zhou, Beijing Tiantan Hospital:
incidence
outcome
acute kidney injury
risk factor

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases